AccessGUDID - DEVICE: Roche Whole Blood Collection Tube (07613336166604)

GUDID

Device Identifier (DI) Information

Brand Name: Roche Whole Blood Collection Tube
Version or Model: 08827907001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08827907001
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 07613336166604
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071674100 *Terms of Use

Device Description: No description.

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:	No
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?
57898	Evacuated blood collection tube IVD, nucleic acid stabilizer	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and a nucleic acid [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] stabilizer. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: b0bd9b65-532e-4618-97ed-4f77a026a818
Public Version Date: November 10, 2021
Public Version Number: 2
DI Record Publish Date: December 19, 2019