G1477 ANAEROBIC PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN FOR GASES AND ELECTROLYTES- tubes, vials, systems, serum separators, blood collection   
Smiths Medical ASD, Inc.

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Drug Facts

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

Povidone-Iodine Prep Pad

Package Label Display Panel

G1477

G1477 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 TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-5275
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-5275-6100 in 1 CASE
11 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 22.5 mL
Part 1 of 1
APLICARE POVIDONE-IODINE  
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0001-322.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1984
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK84098612/14/200505/05/2020
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.081054904manufacture

Revised: 5/2020
Document Id: 08858d65-c3e7-40a5-8f14-d5cd1cd09f1a
Set id: b7dfcc5b-b9a1-41d4-96b7-d11505b11b9a
Version: 5
Effective Time: 20200505
 
Smiths Medical ASD, Inc.