AccessGUDID - DEVICE: Vacuette (29120017575263)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 729073
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 729073
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120017575263
Issuing Agency: GS1
Commercial Distribution End Date: April 14, 2021
Device Count: 50
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® TUBE 1.5 ml 4NC ESR sodium citrate 3.2% 9x120 black cap, PP

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
GHC	TUBE, SEDIMENTATION RATE
GIM	Tubes, vacuum sample, with anticoagulant
JKA	Tubes, vials, systems, serum separators, blood collection

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: 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: f3542cc4-6efb-4a0e-9de3-45873c68e512
Public Version Date: April 16, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016