InSure FIT

Basic Information

• Brand Name: InSure FIT
• Primary DI: 00850093003064
• Version / Model: 01
• Catalog Number: 15022
• Company Name: ENTERIX INC.
• Labeler DUNS: 002224009
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 8
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 8d4a50ac-3108-4ec4-8cf7-a5470052fa29

Device Description

InSure FIT Kit

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
61352	Faecal specimen collection kit IVD, home-use	A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850093003064	GS1
Package	10850093003061	GS1	Carton	10	In Commercial Distribution
Package	10850093003009	GS1	Carton	25	In Commercial Distribution
Package	10850093003108	GS1	Carton	50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K002457	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 99 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 37 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from Heat and Direct Sun Light