AccessGUDID - DEVICE: TriniLIZE™ Stabilyte tubes (15391521421286)

GUDID

Device Identifier (DI) Information

Brand Name: TriniLIZE™ Stabilyte tubes
Version or Model: T6006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TCOAG IRELAND LIMITED

Primary DI Number: 15391521421286
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2019
Device Count: 30
Labeler D-U-N-S® Number*: 985039126 *Terms of Use

Device Description: No description.

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:	Yes
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
KDT	Container, Specimen Mailer And Storage, Sterile

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b493f84a-cbb1-46a0-9fbc-b9297e2b90c1
Public Version Date: July 19, 2019
Public Version Number: 3
DI Record Publish Date: September 12, 2016