G1581 Pro-Vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And Electrolytes () Kit [Smiths Medical Asd, Inc.] -

G1581 PRO-VENT ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHIUM HEPARIN FOR GASES AND ELECTROLYTES () KIT [SMITHS MEDICAL ASD, INC.]
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NDC	51688-5276-6, 52380-0001-5
Set ID	48befa4c-179c-4d0a-b8d0-653fbe6b33ce
Category	MEDICAL DEVICE
Packager	Smiths Medical ASD, Inc.
Generic Name
Product Class
Product Number
Application Number	K952516

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Drug Facts

Povidone-iodine
PURPOSE

Antiseptic

Antiseptic skin preparation
WARNINGS

Do not use

- if allergic to iodine

- in the eyes

For external use only

Ask a doctor before use if injuries are

- deep wounds

- puncture wounds

- serious burns
STOP USE

Stop use and ask a doctor if

- infection occurs

- redness, irritation, swelling or pain persists or increases
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid excessive heat.

Store at room temperature.
INSTRUCTIONS FOR USE

Apply locally as needed.
OTHER SAFETY INFORMATION
- 1% titratable iodine
- Latex free
- For hospital or professional use only
INACTIVE INGREDIENT

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE PREP PAD

ANTISEPTIC

STERILE SOLUTION
PRINCIPAL DISPLAY PANEL

Package Label Display Panel

INGREDIENTS AND APPEARANCE

G1581 PRO-VENT ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHIUM HEPARIN FOR GASES AND ELECTROLYTES
tubes, vials, systems, serum separators, blood collection kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-5276

#	Item Code	Package Description
Packaging
1	NHRIC:51688-5276-6	100 in 1 CASE
1		1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PACKET	1 mL

Part 1 of 1

APLICARE POVIDONE-IODINE
povidone-iodine solution

Product Information
Item Code (Source)	NDC:52380-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-0001-5	1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/1984

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
premarket notification	K952516	12/14/2005

Labeler - Smiths Medical ASD, Inc. (137835299)

Name	Address	ID/FEI	Business Operations
Establishment
Smiths Medical ASD, Inc.		137835299	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aplicare, Inc.		107255002	manufacture

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