4077EG-1 ANAEROBIC PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN FOR GASES AND ELECTROLYTES- kit

4077EG-1 Anaerobic Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin for Gases and Electrolytes by

Drug Labeling and Warnings

4077EG-1 Anaerobic Pulsator Arterial Blood Sampling Kit with Liquid Sodium 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]

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 childrenIn 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

4077EG-1 ANAEROBIC PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN FOR GASES AND ELECTROLYTES 
tubes, vials, systems, serum separators, blood collection kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-5329

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:51688-5329-6	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	1 PACKET	1 mL

Part 1 of 1

APLICARE POVIDONE-IODINE 
povidone-iodine solution

Product Information
Item Code (Source)	NDC: 52380-0111
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: 52380-0111-1	1 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	03/01/1984

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K840986	04/25/2008

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.		107255002	manufacture