InSure FIT

Basic Information

• Brand Name: InSure FIT
• Primary DI: 00850093003033
• Version / Model: 01
• Catalog Number: 16800
• Company Name: ENTERIX INC.
• Labeler DUNS: 002224009
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: 88d8e3d0-cc77-4a03-b1aa-65109693e7bf

Device Description

InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each)

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
OSL	Control, Fecal Occult Blood	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38218	Faecal occult blood IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850093003033	GS1

Premarket Submissions

Submission Number	Supplement Number
K101831	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from heat and direct sun light
• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit