MiniCollect - MiniCollect® TUBE 1 ml LH Lithium Heparin green - Greiner Bio-One GmbH

Duns Number:303639066

Device Description: MiniCollect® TUBE 1 ml LH Lithium Heparin green cap, with cross cut, Spray-dried

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More Product Details

Catalog Number

450477

Brand Name

MiniCollect

Version/Model Number

450477

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

K991843,K991843,K991843

Product Code Details

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Device Record Status

Public Device Record Key

6de09850-a26d-4fba-8666-26a3b0baf6bf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

39120017578599

Quantity per Package

10

Contains DI Package

29120017578592

Package Discontinue Date

-

Package Status

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