HemosIL SynthAFax

Basic Information

• Brand Name: HemosIL SynthAFax
• Primary DI: 08426950087649
• Version / Model: 00020007400
• Catalog Number: 00020007400
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: 6be6d48b-9aba-4b2a-a7e8-79dc73a8e03c

Device Description

HemosIL SynthAFax

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
GFO	ACTIVATED PARTIAL THROMBOPLASTIN	Hematology	864.7925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55981	Activated partial thromboplastin time (APTT) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950087649	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955638	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.