AFIAS-50

Basic Information

• Brand Name: AFIAS-50
• Primary DI: 08806133010068
• Version / Model: FPRR022
• Catalog Number: FPRR022
• Company Name: Boditech Med Inc.
• Labeler DUNS: 689062203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-19
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: a8578f5c-e7de-425f-85e9-9819b87ba232

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
57871	Specimen processing instrument IVD	An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806133010068	GS1

Customer Contacts

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