N/A - Neonatal/Pediatric Syringe Set 40µ Filter with - CHARTER MEDICAL, LTD.

Duns Number:029062325

Device Description: Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

N40-960-37

Brand Name

N/A

Version/Model Number

N40-960-37

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

K990310,K990310

Product Code Details

Product Code

CAK

Product Code Name

Microfilter, Blood Transfusion

Device Record Status

Public Device Record Key

1ea7ac4b-2eb6-4d06-b304-0e32810d3d32

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

00817827024559

Quantity per Package

24

Contains DI Package

00817827024054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CHARTER MEDICAL, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 75
U Unclassified 7