SANTA BÁRBARA CLINIC OF V

CLASSIFICATION OF MEDICAL DEVICES

CLASS I: These are low-risk medical devices, subject to general controls.

to protect or maintain life or for a use of special importance in prevention of
human and do not represent an unreasonable potential risk of disease or injury.
CLASS IIa. They are medical devices of moderate risk, subject to special controls.
manufacturing to demonstrate its safety and effectiveness.
CLASS IIb: These are high-risk medical devices, subject to special controls.
manufacturing to demonstrate its safety and effectiveness.
CLASS III: These are medical devices of very high risk subject to special controls.
to protect or maintain life or for a use of substantial importance in the prevention of d
human, or if its use poses a potential risk of disease or injury.

CLASSIFY
MEDICAL DEVICE NAME
CLASS I CLASS IIa
MINERAL OIL GALLON X 3800 ML X
DISTILLED WATER JUG X 4LITERS X
ANTISEPTIC ALCOHOL X
HYPODERMIC NEEDLE No. 18G
HYPODERMIC NEEDLE No. 19G
HYPODERMIC NEEDLE No. 20G
HYPODERMIC NEEDLE No. 21G
HYPODERMIC NEEDLE No. 23G
HYPODERMIC NEEDLE No. 25G
HYPODERMIC NEEDLE No. 27G
HYPODERMIC NEEDLE No. 30G
COTTON BALL X 10G X
HOSPITAL COTTON PADS X 500 GR
LARGE STERILE DRESSING X
SMALL STERILE DRESSING X
WOOD APPLICATORS X
Cotton applicators X
DISPOSABLE ADULT DENTAL BIB X
Wooden tongue drum X
SURGEON'S RESORTED PUNCH X
BLUE SHORT SLEEVE PATIENT GOWN X
LONG SLEEVE PATIENT SHIRT WITH ELASTIC CUFFS X
BURETROL X
FECAL SAMPLE BOX X
EYE BASKET X
ADULT OXYGEN NASAL CANNULA X
PEDIATRIC OXYGEN NASAL CANNULA X
Guedell or Mayo Cannula No. 2 X
GUDELL OR MAYO CANNULA No. 3 X
SANTA BÁRBARA CLINIC V

CLASSIFICATION OF MEDICAL DEVICES

CLASSIFI
MEDICAL DEVICE NAME
CLASS I CLASS IIa
Guedell or Mayo Cannula No. 4 X
Guedell or Mayo Cannula No. 5 X
INTROCAN CATHETER No. 16
INTROCAN Catheter No. 18
INTROCAN CATHETER No. 20
INTRACATH Catheter No. 22
INTROCAN CATHETER No. 24
JELCO Catheter No. 22
JELCO CATHETER JELCO PLUS POLYURETHANE No. 18
CHROMED CATGUT 6123T 2-0
CHROMED CATGUT U204T 3-0
CHROMED CATGUT U203T 4-0
STERILE SUCTION TUBE 6MM X 3MT
CIDEX OPA SOLUTION GALLON X 3800 ML X
LOVE CONTROL AT STEAM X
ADULT ANESTHESIA CIRCUIT X
PEDIATRIC ANESTHESIA CIRCUIT X
CYSTOFLO-BAG FOR URINE DRAINAGE 2000 Ml X
SCALPEL BLADE No. 15 X
SCALPEL BLADE No. 20 X
PREMIUM ROUND CURAS CUREBAND X
COVERED 'T' INTRAUTERINE DEVICE
ADULT ELECTRODE X
NEEDLELESS MACRODRIP EQUIPMENT WITH SITE IN Y X
EQUIPMENT FOR PHOTOSENSITIVE PUMP
RESERVOIR EQUIPMENT WITH PVC CYLINDRICAL DRAIN PROBE
1/4"-[Link]-19Fr
MICRODRIP INFUSION SET WITHOUT NEEDLE X
HOSPITAL TYPE CLOTH BANDAGE X
TRANSPARENT ADHESIVE TAPE 1" ROLL X
DISPOSABLE SPECTRUM X
SMALL PEAR-SHAPED VAGINAL SPECULUM X
ETHIBOND 0 CT2 B412H
ETHIBOND CT1 B424H
ETHIBOND CT2 B412H
HMEF FILTER (CAMEL NOSE)
Urine collection bottle X
STERILE GAUZE X 3 UNITS X
SANTA BÁRBARA CLINIC OF V

CLASSIFICATION OF MEDICAL DEVICES

CLASSIFY
MEDICAL DEVICE NAME
CLASS I CLASS IIa
ULTRASOUND GEL (CONDUGEL) GALLON X 3750 C.C. X
DISPOSABLE BLUE NURSE CAP X
DISPOSABLE WHITE CAP X
SMALL EXAMINATION LATEX GLOVE X
MEDIUM EXAMINATION LATEX GLOVE X
LARGE LATEX EXAM GLOVE X
STERILE GLOVE SIZE 6.5 X
STERILE GLOVE SIZE 7.0 X
STERILE GLOVE SIZE 7.5 X
STERILE GLOVE SIZE 8.0 X
Oxygen Humidifier X
STEAM BIOLOGICAL INDICATOR
SPORITECH BIOLOGICAL INDICATOR
STEAM CHEMICAL INDICATOR
1 Ml 27G SYRINGE FOR INSULIN
Syringe 5 ml 21 X 1 1/2
10 ml syringe 21G x 1-1/2
20 Ml Syringe C/A
Syringe 50 Ml 3 PTS S/A
DISPOSABLE COMPLETE CYTOLOGICAL KIT FROSTED SLIDE X
DISPOSABLE CYTOLOGICAL KIT SIZE S X
ADULT NEBULIZATION KIT X
PEDIATRIC MICRONEBULIZATION KIT X
VENTURY ADULT KIT X
THREE-WAY VALVE X
Oxygen administration hose x 2 m X
MANILLA PATIENT IDENTIFICATION BRACELET X
MANILA PEDIATRIC IDENTIFICATION BRACELET X
ADULT OXYGEN MASK X
PEDIATRIC OXYGEN MASK X
GYNECOLOGICAL MECHA R2246 X
MERSILENE 5/0 S14 1760G
DISPOSABLE THREE-WAY KEY (DISCOFIX) X
THERMOREFLECTIVE PAPER FOR ELECTROCARDIOGRAPH X
ADULT RETURN PLATE TYPE STD X
DISPOSABLE SHOE COVERS
DISPOSABLE SPP BLUE SHOE COVERS
DISPOSABLE SIMPLE LEG GUARD
CONDOMS
PROLENE SUTURE 2-0 SC26 8185T X
PROLENE SUTURE 3-0 PS1 P8663T X
SAINT BARBARA CLINIC OF V

CLASSIFICATION OF MEDICAL DEVICES

CLASSIFY
MEDICAL DEVICE NAME
CLASS I CLASS IIa
PROLENE SUTURE 4-0 PS2 P8682T X
PROLENE SUTURE 5-0 PS2 P8686T X
PROLENE SUTURE 5-0 P3 P8698T X
PROLENE SUTURE 6-0 P1 P8697T X
PLASTIC EYE PROTECTOR X
SURGICAL QUIRUCIDAL SOAP GALLON X X
QUIRUGER PLU S STERILIZING GALLON X 3750 CC X
QUIRUGER ACTIVATING SOLUTION X
DISPOSABLE ADJUSTABLE SHEET FOR COT X
SEDA 2/0 SA85T
SEDA 3/0 SA84T
SEDA 2/0 SH K833H
SEDA 3/0 SH K832H
CLOSED DRAINAGE SYSTEM FOR WOUNDS
SONDA NELATÓN No. 6 x 40 M X
SONDA NELATÓN No. 8 x 40 M X
SONDA NELATÓN No. 14 x 40 M X
FOLEY CATHETER No. 14 x 5 CC 2 WAYS X
FOLEY CATHETER No. 16 x 30 CC 2 WAYS X
FOLEY CATHETER No. 22 x 30 CC 2 WAYS X
SPINOCAN CALIBRE G 26 x+A159 3 1/2
SPINOCAN CALIBER G 27 x 3 1/2
TIE MASK X
ELASTIC STRAP MASKS X
BLUE ELASTIC FACE MASKS X
INTERMITTENT HEPARINIZED STOPPER X
DIGITAL ELECTRONIC THERMOMETER X
ENDOTRACHEAL TUBE No. 4.5 WITHOUT BALLOON X
ENDOTRACHEAL TUBE No. 5.5 WITHOUT BALLOON X
ENDOTRACHEAL TUBE C/B 9.0 X
ENDOTRACHEAL TUBE S-B 3.0 X
ENDOTRACHEAL TUBE S-B 3.5 MM/UNIT X
ENDOTRACHEAL TUBE S-B 3.0 X
ENDOTRACHEAL TUBE S-B 4.0 MM X
ENDOTRACHEAL TUBE S-B 5.0 MM X
SALE OF LAMINATED COTTON 3"X5 X
SALE OF LAMINATED COTTON 4"X5 X
SALE OF LAMINATED COTTON 5"X5" X
SALE OF LAMINATED COTTON 6"X5 X
ELASTIC BAND 3"x5 X
SANTA BÁRBARA CLINIC V

CLASSIFICATION OF MEDICAL DEVICES

CLASSIFY
MEDICAL DEVICE NAME
CLASE I CLASE IIa
ELASTIC BAND 4"x5 X
ELASTIC BAND 5"x5 X
ELASTIC BAND 6"x5 X
SALE OF GYPSUM 4"x5 X
GYPSUM SALE 5"x5" X
SALE OF GYPSUM 6"x5 X
VICRYL 0 CT1 B346H
VICRYL 1 CT1 B347H
VICRYL 2-0 CT1 J339H
VICRYL 3-0 SH J316H
VICRYL 4-0 RB-1 J304H
VICRYL 5-0 RB-1 J303H
VICRYL 5-0 P3-1 JP493
VALLE DE TENZA S.A.
GARAGOA - BOYACÁ
NIT.: 900115061-9

not intended for

deterioration of health

it is in the phase of

the design and

, intended for
deterioration of health

Communication
CLASE IIb CLASE III

X
X
X
X
X
X
X
X

X
VALLE DE TENZA S.A.
GARAGOA - BOYACÁ
NIT.: 900115061-9

COMMUNICATION
CLASE IIb CLASE III

X
X
X
X
X
X
X
X
X
X
X

X
X
 X

VALLE DE TENZA S.A.

GARAGOA - BOYACÁ
NIT.: 900115061-9

APPLICATION
CLASS IIb CLASS III

X
X
X
X
X
X
X
X
 X

TENZA VALLEY S.A.

GARAGOA - BOYACÁ
NIT.: 900115061-9

LOCATION
CLASE IIb CLASE III

X
X
X
X
VALLE DE TENZA S.A.
GARAGOA - BOYACÁ
NIT.: 900115061-9

ICACIÓN
CLASE IIb CLASE III

X
X
X
X
X
X
X
 SAINT BARBARA CLINIC V

CLASSIFICATION OF MEDICAL DEVICES

MEDICATION NAME

ACETYLSALICYLIC ACID TAB X 100 MG

ISOSORBIDE DINITRATE TAB X 5MG

MINERAL OIL GALLON X 3800 ML
ALBASOL EYE DROPS.
MIDRYACYL EYE DROPS 15 ML
OQ-SEINA EYE DROPS 15 ML
OQ-SEPTIC DROPS OFT. X15 ML
TROPIFUN Ophthalmics
HYDROCORTISONE TOPICAL CREAM 1% TUBE X 15GR
OXIMETAZOLONE (WASSERFRIN) NASAL SOLUTION 0.50% BOTTLE X 15 ML
NITROFURAZONE OINTMENT (FURACIN) TUBE X 40GR
LIDOCAINE SPRAY (ROXICAIN) BOTTLE X 80 ML
IPRATROPIUM BROMIDE (CIPLATROPIUM) 15 ML BOTTLE

SALBUTAMOL (CIPLABOTUL) SOL. FOR NEBULIZATION

TERBUTALINE (TERBUROP) SOL. FOR NEBULIZATION
SODIUM CHLORIDE 0.9% BAG X 100 ML
SODIUM CHLORIDE 0.9% BAG X 250 ML
SODIUM CHLORIDE 0.9% BAG X 500 ML

STERILE WATER FOR INJECTION BAG X 500 ML

ADRENALINE EPINEPHRINE AMP X 1MG/ML

ACETYLCYSTEINE (FLUIMUCIL) 10% AMP X 25 ML
AMINOPHYLLINE AMP X 240 MG
AMIODARONE AMP X 150 MG
ATROPINE AMP X 1MG/ML
SODIUM BICARBONATE AMP X 10 ML
ROCURONIUM BROMIDE AMP X 50MG
BUPIVACAINE (BUPIROP) 0.5% AMP X 10ML
HEAVY BUPIVACAINE (BUPIROP) AT 5% AMP X 10ML
CEFALOTINA AMP X1GR
CLINDAMYCIN AMP X 600 MG
POTASSIUM CHLORIDE AMP X 10ML
SODIUM CHLORIDE AMP X 10ML
DEXAMETHASONE AMP X 8MG
Dextrose 5% A/D bag x 500 ml
DICLOFENAC AMP X 75MG/ML
DIPIRONE AMP X 1GR
DOPAMINE AMP X 200MG/5ML
PHENITOIN AMP X 250 MG
Furosemide Amp X 20 mg
GENTAMICIN AMP X 80 MG
GENTAMICIN AMP X 160 MG
Calcium Gluconate AMP at 10%
SODIUM HEPARIN AMP X 5,000 IU
HYDROCORTISONE AMP X 100 MG
HYOSCINE+DIPYRONE AMP X 20GM
Lidocaine 1% Epinephrine (Roxicain) Ampule x 50 ml
LIDOCAINE 2% EPINEPHRINE (ROXICAIN) AMP X 50 ML
LIDOCAINE (ROXICAINA) 1% SIMPLE AMP X 50ML
LIDOCAINE (ROXICAINA) JELLY TUBE X 30ML
METOCLOPRAMIDE AMP X 10MG/2ML
METOPROL AMP 5 MG
MIDAZOLAM AMP X 5MG/5ML
MORPHINE AMP X 10 MG
NEOSTIGMINE AMP X 5MG
NITROGLYCERIN AMP X 50MG/10ML
NOREPINEPHRINE AMP X 4MG/4ML
ONDANSETRON (ONDAX) AMP X 8 MG/4ML
PROPOFOL 1% VIAL X 20ML

RANITIDINE AMP X 50MG

REMIFENTANIL AMP X 2MG (BOX X 5)
MAGNESIUM SULFATE AMP AT 20%
SUCCINYLCHOLINE CHLORIDE (MIOACTINE) AMP X 100 MG
SEVORANE LIQ (SEVOFLURANO) AMP X 250 ML
BALANCED SALINE SOLUTION (OQ BALANS) BAG X 500ML
RINGER'S LACTATE SOLUTION X 500 ML
TERBUTALINE AMP X 0.5 MG/ML
VALLE DE TENZA S.A.
GARAGOA - BOYACÁ
NIT: 900115061-9