AccessGUDID - DEVICE: Vacuette (29120017576086)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 455029
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 455029
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120017576086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® TUBE 9 ml Urine Culture 16x100 yellow cap-black ring, Conical Base, non-ridged

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:	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?
58150	Evacuated urine specimen container IVD, boric acid (H3BO3)	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the preservative boric acid (H3BO3), intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	CONTAINER, SPECIMEN, STERILE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5567b6b9-20c2-483b-983c-445cc21de0dd
Public Version Date: January 22, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020