G1806 PULSATOR ARTERIAL BLOOD SAMPLING KIT: Package Insert and Label Information

G1806 PULSATOR ARTERIAL BLOOD SAMPLING KIT-
Smiths Medical ASD, Inc.

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
(click image for full-size original)

Package Label Display Panel

G1806
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
G1806 PULSATOR ARTERIAL BLOOD SAMPLING KIT Tubes, Vials, Systems, Serum Separators, Blood Collection
G1806 PULSATOR ARTERIAL BLOOD SAMPLING KIT
kit
Product Information
Product Type Item Code (Source) NHRIC:51688-6535
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:51688-6535-6 100 KIT in 1 CASE contains a KIT
1 1 KIT in 1 KIT This package is contained within the CASE (51688-6535-6)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 PACKET 1 mL
Part 1 of 1
APLICARE POVIDONE-IODINE PREP PAD
povidone-iodine solution
Product Information
Item Code (Source) NDC:52380-0111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC
SODIUM HYDROXIDE
NONOXYNOL-9
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52380-0111-1 1 mL in 1 PACKET None
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 K952516 05/12/2016
Labeler — Smiths Medical ASD, Inc. (137835299)
Establishment
Name Address ID/FEI Operations
Smiths Medical ASD, Inc. 137835299 manufacture
Establishment
Name Address ID/FEI Operations
Aplicare, Inc. 081054904 manufacture

Revised: 05/2020 Smiths Medical ASD, Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.