G1193 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHIUM 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 Prep Pad

Povidone Prep Pad

Package Label Display Panel

G1193

G1193 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH DRY LITHIUM HEPARIN FOR GASES AND ELECTROLYTES 
tubes, vials, systems, serum separators, blood collection kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-4103
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-4103-6100 in 1 CASE
11 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 0.5 mL
Part 1 of 1
APLICARE POVIDONE-IODINE PREP PAD 
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-4111
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:52380-4111-10.5 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 finalpart333A05/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK95251612/14/200511/05/2019
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.081054904manufacture

Revised: 11/2019
Document Id: 57f28e9a-c71b-48f3-99c9-c42ad11c5098
Set id: f0efc18b-9495-4c53-bc5f-9b1dc8448d63
Version: 7
Effective Time: 20191105
 
Smiths Medical ASD, Inc.