| Primary Device ID | 06970706368107 |
| NIH Device Record Key | 17e05be5-9631-4263-a128-0c0b45b78748 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reusable NIBP Cuff |
| Version Model Number | BP-80BS |
| Company DUNS | 544423370 |
| Company Name | Orantech 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970706368107 [Primary] |
| DXQ | Blood Pressure Cuff |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-01 |
| Device Publish Date | 2020-12-24 |
| 06970706368114 | With inflation bag, Single tube Thigh Range 38-50cm |
| 06970706368107 | With inflation bag, Single tube Large Adult Long Range 31-53cm |
| 06970706368091 | With inflation bag, Single tube Large Adult Range 31-40cm |
| 06970706368084 | With inflation bag, Single tube Adult Extra Long Range 23-46cm |
| 06970706368077 | With inflation bag, Single tube Adult Range 23-33cm |
| 06970706368060 | With inflation bag, Single tube SmallAdult Range 17-25cm |
| 06970706368053 | With inflation bag, Single tube Child Range 12-19cm |
| 06970706368046 | With inflation bag, Single tube Infant Range 8-13cm |
| 06970706368039 | With inflation bag, Single tube Neonatal Range 6-11cm |