AccessGUDID - DEVICE: Vacuette (29120017576963)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 454322CA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 454322CA
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120017576963
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2017
Device Count: 50
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, special label, non-ridged, 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?
42585	Evacuated blood collection tube IVD, sodium citrate	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., for plasma coagulation studies, mononuclear cell preparation). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GIM	Tubes, vacuum sample, with anticoagulant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971221	000

Device Exempt from Premarket Submission: No 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: 4f6d4f3f-0f9e-49e5-8a1a-91c9d3eeb705
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016