| Primary Device ID | 00850093003071 |
| NIH Device Record Key | 8b97dbde-efbd-41b1-8665-bfa9f0ba018a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InSure FIT |
| Version Model Number | 01 |
| Catalog Number | 11018 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 37 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850093003071 [Primary] |
| KHE | Reagent, Occult Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-03 |
| 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 |