AccessGUDID - DEVICE: Hematocrit capillaries (04050674084833)

GUDID

Device Identifier (DI) Information

Brand Name: Hematocrit capillaries
Version or Model: 2074
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2074
Company Name: Andreas Hettich GmbH & Co. KG

Primary DI Number: 04050674084833
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2020
Device Count: 100
Labeler D-U-N-S® Number*: 316403245 *Terms of Use

Device Description: Hematocrit capillaries

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61387	Capillary blood collection tube IVD, sodium heparin	A non-sterile glass or plastic collection tube containing the anticoagulant sodium heparin, intended to be used for the collection preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GHY	Hematocrit, Tube, Rack, Sealer, Holder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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