InSure® ONE™

Basic Information

• Brand Name: InSure® ONE™
• Primary DI: 00850093003286
• Version / Model: 01
• Catalog Number: 11018.01
• Company Name: ENTERIX INC.
• Labeler DUNS: 002224009
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-05
• Public Version: 4
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: e0caaf68-9b44-477e-a005-f872d5110b1b

Device Description

InSure® ONE™ Test Cards for QC - 50 pack

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
KHE	Reagent, 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	00850093003286	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170548	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 37 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 99 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from heat and direct sunlight