AccessGUDID - DEVICE: Thromborel® S (00630414023465)

GUDID

Device Identifier (DI) Information

Brand Name: Thromborel® S
Version or Model: 10873565
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OUHP53
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414023465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X

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:	No
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?
55986	Prothrombin time (PT) 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 quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJS	TEST, TIME, PROTHROMBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003870	000

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12619e89-5270-4c74-bff7-a36ec77d12e1
Public Version Date: November 27, 2023
Public Version Number: 6
DI Record Publish Date: February 15, 2017