InSure® ONE™ 11018.01

GUDID 00850093003286

InSure® ONE™ Test Cards for QC - 50 pack

ENTERIX INC.

Faecal occult blood IVD, control

• Primary Device ID: 00850093003286
• NIH Device Record Key: e0caaf68-9b44-477e-a005-f872d5110b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSure® ONE™
• Version Model Number: 01
• Catalog Number: 11018.01
• 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: false
• 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

Customer Support Contacts

• Phone: 18005313681
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850093003286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170548

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: 2018-01-05

On-Brand Devices [InSure® ONE™]

• 00850093003354: InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit
• 00850093003347: InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bu
• 30850093003317: InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01
• 00850093003309: InSure® ONE™ Sample Kit - NOT FOR SALE Contains 2 Collection Kits, 2 individually-pouched Tes
• 00850093003293: InSure® ONE™ Run Buffer - 1 Liter Bottle
• 00850093003286: InSure® ONE™ Test Cards for QC - 50 pack
• 00850093003279: InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit
• 00850093003231: InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run