AccessGUDID - DEVICE: Thrombo-TIC 1:25 pur (04061609000712)

GUDID

Device Identifier (DI) Information

Brand Name: Thrombo-TIC 1:25 pur
Version or Model: 004015-6012DMD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOANALYTIC GmbH, biomed. Analysentechnik

Primary DI Number: 04061609000712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 327536728 *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):	No
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?
55861	Platelet count IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of platelet (thrombocyte) count in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCG	Fluid, Diluting, Manual Cell

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59fa8ad1-d9ed-4e5c-a90e-19810cd09f80
Public Version Date: March 04, 2019
Public Version Number: 1
DI Record Publish Date: February 01, 2019