Thromborel® S

Basic Information

• Brand Name: Thromborel® S
• Primary DI: 00630414023465
• Version / Model: 10873565
• Catalog Number: OUHP53
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 6
• Public Version Date: 2023-11-27
• Public Version Status: Update
• Public Device Record Key: 12619e89-5270-4c74-bff7-a36ec77d12e1

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJS	TEST, TIME, PROTHROMBIN	Hematology	864.7750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414023465	GS1
Unit of Use	00842768018749	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003870	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius