AccessGUDID - DEVICE: Thromborel® S (00842768011306)

GUDID

Device Identifier (DI) Information

Brand Name: Thromborel® S
Version or Model: 10446442
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OUHP29
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768011306
Issuing Agency: GS1
Commercial Distribution End Date: September 06, 2018
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?
55983	Prothrombin time (PT) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method.	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: decc364d-65a3-4fb4-932b-52867df7aa5d
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016