VQE2001XD - 4 Empty Bags 300 mL - 300ml Quad Splitting Empty Bags. - MACO PRODUCTIONS

Duns Number:265492868

Device Description: 300ml Quad Splitting Empty Bags.

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More Product Details

Catalog Number

VQE2001XD

Brand Name

VQE2001XD - 4 Empty Bags 300 mL

Version/Model Number

VQE

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

BK030008,BK030008

Product Code Details

Product Code

CAK

Product Code Name

Microfilter, Blood Transfusion

Device Record Status

Public Device Record Key

1962544c-6fad-4256-b778-b25855360a05

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

13567050069905

Quantity per Package

15

Contains DI Package

03567050069908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MACO PRODUCTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 9