Hematocrit capillaries - Hematocrit capillaries - Andreas Hettich GmbH & Co. KG

Duns Number:316403245

Device Description: Hematocrit capillaries

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More Product Details

Catalog Number

2074

Brand Name

Hematocrit capillaries

Version/Model Number

2074

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2020

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GHY

Product Code Name

Hematocrit, Tube, Rack, Sealer, Holder

Device Record Status

Public Device Record Key

31f498bd-a8c5-4d5e-b4a5-c0c048ffbc78

Public Version Date

February 11, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

04050674019279

Quantity per Package

10

Contains DI Package

04050674084833

Package Discontinue Date

February 05, 2020

Package Status

Not in Commercial Distribution

Package Type

-

"ANDREAS HETTICH GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 38