InSure FIT 15022

GUDID 00850093003064

InSure FIT Kit

ENTERIX INC.

Home faecal specimen collection kit

• Primary Device ID: 00850093003064
• NIH Device Record Key: 8d4a50ac-3108-4ec4-8cf7-a5470052fa29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSure FIT
• Version Model Number: 01
• Catalog Number: 15022
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 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 99 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Heat and Direct Sun Light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850093003064 [Primary]
GS1	10850093003009 [Package]; Package: Carton [25 Units]; In Commercial Distribution
GS1	10850093003061 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	10850093003108 [Package]; Package: Carton [50 Units]; In Commercial Distribution

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: 2016-09-14

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