InSure FIT 80025

GUDID 00850093003019

InSure FIT Developer Kit

ENTERIX INC.

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical

• Primary Device ID: 00850093003019
• NIH Device Record Key: e8935860-46ac-4d86-9c5d-b1313f2cf680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSure FIT
• Version Model Number: 01
• Catalog Number: 80025
• Company DUNS: 002224009
• Company Name: ENTERIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850093003019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002457

FDA Product Code

• KHE: Reagent, Occult Blood

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [InSure FIT]

• 00850093003187: InSure FIT Sample Kit - NOT FOR SALE Contains 2 Patient Collection Kits, 2 Test Strips, and 1 Ru
• 00850093003095: InSure FIT Run Buffer - 1 Liter Bottle
• 10850093003085: InSure FIT Test Strip
• 00850093003071: InSure FIT Test Cards for QC - 50 pack
• 00850093003064: InSure FIT Kit
• 00850093003040: InSure FIT Combo Pack
• 00850093003033: InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each)
• 00850093003019: InSure FIT Developer Kit