| Primary Device ID | 10852937003275 | 
| NIH Device Record Key | ed31cfa5-e37d-4104-816a-07029fb5b86f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | INNOVATE MEDICAL | 
| Version Model Number | 820-5409 | 
| Catalog Number | 820-5409 | 
| Company DUNS | 050339980 | 
| Company Name | INNOVATE MEDICAL, LLC | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | |
| Phone | 423-461-3558 | 
| QA@innovatemed.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00852937003278 [Primary] | 
| GS1 | 10852937003275 [Package] Contains: 00852937003278 Package: Inner Pack [1 Units] In Commercial Distribution  | 
| GS1 | 40852937003276 [Package] Package: case [20 Units] In Commercial Distribution  | 
| GAX | Tourniquet, Nonpneumatic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-11-22 | 
| Device Publish Date | 2022-11-14 | 
| 10852937003305 | Innovate Medical Esmark Bandage Blue 6x12 | 
| 10852937003299 | Innovate Medical Esmark Bandage Blue 6x9 | 
| 10852937003282 | Innovate Medical Esmark Bandage Blue 4x12 | 
| 10852937003275 | Innovate Medical Esmark Bandage Blue 4x9 | 
| 10852937003060 | Innovate Medical Esmark Bandage Blue 6x12 | 
| 10852937003053 | Innovate Medical Esmark Bandage Blue 6x9 | 
| 10852937003046 | Innovate Medical Esmark Bandage Blue 4x12 | 
| 10852937003039 | Innovate Medical Esmark Bandage Blue 4x9 | 
| 10852937003022 | Blood Culture Kit | 
| 00852937003018 | Blood Culture Kit |