IV Syringe - IV SYRINGE, 10cc - NORTH AMERICAN RESCUE, LLC

Duns Number:832426782

Device Description: IV SYRINGE, 10cc

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More Product Details

Catalog Number

ZZ-0070

Brand Name

IV Syringe

Version/Model Number

ZZ-0070

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2018

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

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

28de72f4-4c3c-4d2c-b6a4-6f650b48b4cc

Public Version Date

January 27, 2021

Public Version Number

3

DI Record Publish Date

July 13, 2018

Additional Identifiers

Package DI Number

10842209107343

Quantity per Package

100

Contains DI Package

00842209107346

Package Discontinue Date

September 22, 2018

Package Status

Not in Commercial Distribution

Package Type

Box

"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