AccessGUDID - DEVICE: US Biotek Laboratories (00860010959268)

GUDID

Device Identifier (DI) Information

Brand Name: US Biotek Laboratories
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCK001
Company Name: U.S. Biotek Laboratories LLC

Primary DI Number: 00860010959268
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094709776 *Terms of Use

Device Description: Single-use convenient serum collection kit includes collection tube(s), and return packing for mailing to testing laboratory.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
42368	Evacuated blood collection tube IVD, clot promoter	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood clot promoter (e.g., thrombin). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., rapid serum chemistry determinations). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 61455468-b475-44b7-9454-f6f0ea023086
Public Version Date: September 25, 2023
Public Version Number: 1
DI Record Publish Date: September 15, 2023