Pefakit

Basic Information

• Brand Name: Pefakit
• Primary DI: 07640175460020
• Version / Model: 502-22
• Catalog Number: 502-22
• Company Name: Pentapharm AG
• Labeler DUNS: 480618766
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-25
• Public Version: 5
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 761a053c-789f-41c9-bad0-596fb6ebc453

Device Description

Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
41694	Activated protein C resistance ratio (APCR) IVD, control	A material which is used to verify the performance of an assay intended to be used to determine the activated protein C resistance ratio (APCR) of a clinical specimen by measuring clotting time with and without added activated protein C.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640175460020	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042760	000

Storage Conditions

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