N/A - Neonatal/Pediatric Syringe Set 150µ Filter, 30cc - CHARTER MEDICAL, LTD.

Duns Number:029062325

Device Description: Neonatal/Pediatric Syringe Set 150µ Filter, 30cc Syringe, 150 mL bag

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More Product Details

Catalog Number

03-BDP-30

Brand Name

N/A

Version/Model Number

03-BDP-30

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

K000685,K000685

Product Code Details

Product Code

BRZ

Product Code Name

Set, Blood Transfusion

Device Record Status

Public Device Record Key

aab30059-3e0a-4bd3-b48c-37176e10b4bf

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

00817827022685

Quantity per Package

18

Contains DI Package

00817827022180

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