AccessGUDID - DEVICE: MiniCollect (29120017578509)

GUDID

Device Identifier (DI) Information

Brand Name: MiniCollect
Version or Model: 450447
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 450447
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120017578509
Issuing Agency: GS1
Commercial Distribution End Date: May 12, 2021
Device Count: 100
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: MiniCollect® TUBE 0.5 ml 9NC Coagulation sodium citrate 3.2% blue cap, with cross cut

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?
58139	Non-evacuated blood collection tube IVD, sodium citrate	A non-evacuated, non-sterile glass or plastic tube, sealed with a stopper, containing the 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). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
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: No
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: 24966144-5234-4d80-ba65-64086b9ef29a
Public Version Date: May 13, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016