G1716 Pro-Vent Arterial Blood Sampling Kit with Dry Lithum Heparin for Gases and Electrolytes by Smiths Medical ASD, Inc. / Aplicare, Inc.

G1716 Pro-Vent Arterial Blood Sampling Kit with Dry Lithum Heparin for Gases and Electrolytes by

Drug Labeling and Warnings

G1716 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]

G1716 PRO-VENT ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHUM HEPARIN FOR GASES AND ELECTROLYTES- regional anesthesia kit   
Smiths Medical ASD, Inc.

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APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
[Aplicare, Inc.]

3/4 Ounce Povidone Iodine Packet

POVIDONE-IODINE PREP PAD

Active Ingredient                                   Use
Povidone-iodine USP 10%.....................Antiseptic

Directions  Apply locally as needed.

STERILE unless opened or damaged.
Other Information    Prep pad size 1 - 1/4" x 1 - 1/2"

1% titratable          Latex Free
FOR HOSPITAL OR PROFESSIONAL USE ONLY

See Drug Facts for Full Disclosure
Warnings
Do not use if allergic to iodine

For external use only

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

Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burns

Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases

Package Label Display Panel

Package Label Display Panel

G1716 PRO-VENT ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHUM HEPARIN FOR GASES AND ELECTROLYTES 
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-9788

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:51688-9788-6	100 in 1 CASE
1		1 in 1 PACKAGE, COMBINATION

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	12/14/2005	02/05/2020

Labeler - Smiths Medical ASD, Inc. (137835299)

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

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

Revised: 2/2020

Document Id: 0e93b826-daa2-40cc-ba4b-974fceaa5cfb

55439-4

Set id: 10a6ce34-ca1a-4c4f-906e-ec7d3348e489

Version: 2

Effective Time: 20200205

 

Smiths Medical ASD, Inc.