| Primary Device ID | 00194832000106 |
| NIH Device Record Key | 54f2e47f-504d-4c83-8404-e980e30229da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VenaOne, Pair |
| Version Model Number | 08-0030 |
| Company DUNS | 115621579 |
| Company Name | Ortho8 Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00194832000106 [Primary] |
| GS1 | 10194832000103 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 20194832000100 [Package] Contains: 10194832000103 Package: Case (Pallet) [24 Units] In Commercial Distribution |
| JOW | Sleeve, Limb, Compressible |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2022-11-18 |
| 01019483200028 - Circul8 Pro, Pair | 2022-11-28 |
| 10194832000035 - Luxe DVT, Pair | 2022-11-28 |
| 10194832000059 - Defender, Pair | 2022-11-28 |
| 01019483200073 - VenaPro, Pair | 2022-11-28 |
| 00194832000106 - VenaOne, Pair | 2022-11-28 |
| 00194832000106 - VenaOne, Pair | 2022-11-28 |
| 10194832000110 - VenaOne, Charging Station with Battery Set | 2022-11-28 |
| 00194832000175 - VenaOne, Pair of Batteries | 2022-11-28 |
| 00194832000144 - VenaOne, Disposable Wraps, Box of 20 pairs | 2022-11-28 |