BIOPHEN UFH Control C1

Basic Information

• Brand Name: BIOPHEN UFH Control C1
• Primary DI: 03663537042904
• Version / Model: 224101
• Catalog Number: 224101
• Company Name: HYPHEN BIOMED
• Labeler DUNS: 503499167
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5b9d4842-c19e-4d7b-b531-0820806a7a49

Device Characteristics

• Single Use: Yes
• 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
GGN	Plasma, Coagulation Control	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56273	Heparin anti-Xa IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03663537042904	GS1

Premarket Submissions

Submission Number	Supplement Number
K051472	000

Storage Conditions

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