| Primary Device ID | 00786511243135 |
| NIH Device Record Key | 3bd3bb87-70b3-4963-8616-63a4e147a136 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pulse Oximeter |
| Version Model Number | 459-BKW |
| Company DUNS | 078803608 |
| Company Name | RASHMAN CORPORATION |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00786511243135 [Primary] |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-17 |
| Device Publish Date | 2018-12-17 |
| 00786511243159 | FINGERTIP PULSE OXIMETER-PUW-BX |
| 00786511243142 | FINGERTIP PULSE OXIMETER-HKW-BX |
| 00786511243135 | FINGERTIP PULSE OXIMETER-BKW-BX |
| 00786511086404 | SB BASIC PULSE OXIMETER-PUR-BX |
| 00786511086398 | SB BASIC PULSE OXIMETER-HPK-BX |
| 00786511086381 | SB BASIC PULSE OXIMETER-CGY-BX |
| 00786511086374 | SB BASIC PULSE OXIMETER-BLK-BX |
| 00786511083120 | BASIC PULSE OXIMETER-CGY-BX |
| 00786511075125 | BASIC PULSE OXIMETER-PUR-BX |
| 00786511075118 | BASIC PULSE OXIMETER-HPK-BX |
| 00786511072612 | BASIC PULSE OXIMETER-BLK-BX |