NAR Kit - KIT, CCR-MARINER - ORG; This kit contains item(s) - NORTH AMERICAN RESCUE, LLC

Duns Number:832426782

Device Description: KIT, CCR-MARINER - ORG; This kit contains item(s) labeled MRI unsafe.

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More Product Details

Catalog Number

80-0107

Brand Name

NAR Kit

Version/Model Number

80-0107

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

bf0388fa-bd5b-4441-a9d1-6e3886aa04b5

Public Version Date

July 30, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2018

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