MiniCollect - MiniCollect® TUBE 0.25 ml K3E K3EDTA lavender - Greiner Bio-One GmbH

Duns Number:303639066

Device Description: MiniCollect® TUBE 0.25 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried

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More Product Details

Catalog Number

450476

Brand Name

MiniCollect

Version/Model Number

450476

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2022

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

K982999,K982999,K982999

Product Code Details

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Device Record Status

Public Device Record Key

de9f9a03-3326-4654-bcbf-6dc9713feb2d

Public Version Date

May 02, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

39120017578582

Quantity per Package

10

Contains DI Package

29120017578585

Package Discontinue Date

April 29, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"GREINER BIO-ONE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 21