G1675 Pro-Vent Arterial Blood Sampling Kit with Dry Lithum Heparin for Gases and Electrolytes by Smiths Medical ASD, Inc. / Aplicare, Inc.

G1675 Pro-Vent Arterial Blood Sampling Kit with Dry Lithum Heparin for Gases and Electrolytes by

Drug Labeling and Warnings

G1675 Pro-Vent Arterial Blood Sampling Kit with Dry Lithum Heparin for Gases and Electrolytes by is a Other medication manufactured, distributed, or labeled by Smiths Medical ASD, Inc., Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

G1675 PRO-VENT ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHUM HEPARIN FOR GASES AND ELECTROLYTES- tubes, vials, systems, serum separators, blood collection   
Smiths Medical ASD, Inc.

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Povidone-iodine

Antiseptic

Antiseptic skin preparation

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 and ask a doctor if- infection occurs

- redness, irritation, swelling or pain persists or increases

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.

Apply locally as needed.

• 1% titratable iodine
• Latex free
• For hospital or professional use only

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

APLICARE

POVIDONE-IODINE PREP PAD

ANTISEPTIC

STERILE SOLUTION

Package Label Display Panel

G1675 PRO-VENT ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHUM HEPARIN FOR GASES AND ELECTROLYTES 
tubes, vials, systems, serum separators, blood collection kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-5124

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:51688-5124-6	100 in 1 CASE
1		1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PACKET	1 mL

Part 1 of 1

APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution

Product Information
Item Code (Source)	NDC: 52380-4111
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-4111-2	0.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K952516	05/31/2017	01/03/2020

Labeler - Smiths Medical ASD, Inc. (137835299)

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

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare, Inc.		081054904	manufacture

Revised: 1/2020

Document Id: aa204bde-2f6d-41d7-8bc8-4353cbf88f31

55439-4

Set id: 09141d86-7cda-463d-a9fd-f932e62030f3

Version: 3

Effective Time: 20200103

 

Smiths Medical ASD, Inc.