| Primary Device ID | 10860003583002 |
| NIH Device Record Key | f653c014-9d8a-4a66-b9c0-8a69e2ba71ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One Degree Medical |
| Version Model Number | ODM-1000 |
| Company DUNS | 065180232 |
| Company Name | ONE DEGREE MEDICAL HOLDINGS, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003583005 [Primary] |
| GS1 | 10860003583002 [Package] Contains: 00860003583005 Package: Case [24 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
[10860003583002]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
| 10860003583019 | Fluid Warmer Drape 44" x 66" (ODM-1100) |
| 10860003583002 | Fluid Warmer Drape 44" x 44" (ODM-1000) |
| 10860003583033 | Fluid Warmer Drape 44" x 60" (ODM-2066) |
| 10860003583026 | Fluid Warmer Drape 44" x 60" (ODM-2038) |
| 00860003583067 | Fluid Warming System Stand - ODM-STN01 |
| 00860003583050 | 3.8L Capacity Fluid Warming Unit - ODM-3038 |
| 00860003583043 | 6.6L Capacity Fluid Warming Unit - ODM-3066 |