HEMOSURE®

Basic Information

• Brand Name: HEMOSURE®
• Primary DI: 00857338006040
• Version / Model: PRE-PACK iFOB20
• Catalog Number: PRE-PACK iFOB20
• Company Name: HEMOSURE INC.
• Labeler DUNS: 806777541
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 9673e7f1-ed70-487e-bd0a-37e14882424f

Device Description

Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One Buffer Tube in Each Mailer

Device Characteristics

• Single Use: Yes
• 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
KHE	Reagent, Occult Blood	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54532	Faecal occult blood IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857338006040	GS1
Unit of Use	00857338006002	GS1