AccessGUDID - DEVICE: Vacuette (29120049208641)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 456163
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 456163
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120049208641
Issuing Agency: GS1
Commercial Distribution End Date: May 27, 2022
Device Count: 50
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM, USA

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?
57927	General tissue specimen container IVD, fixative/saline	A covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

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: a504df9b-dfdb-4bb3-bf64-50b5b9584a88
Public Version Date: December 08, 2022
Public Version Number: 4
DI Record Publish Date: January 14, 2021