NAR Kit - KIT, LTOWB - NORTH AMERICAN RESCUE, LLC

Duns Number:832426782

Device Description: KIT, LTOWB

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More Product Details

Catalog Number

83-0029

Brand Name

NAR Kit

Version/Model Number

83-0029

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

POQ

Product Code Name

Blood Transfusion Kit

Device Record Status

Public Device Record Key

c69a7d32-7843-4dd0-ace0-41c469c40753

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTH AMERICAN RESCUE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 23