| Primary Device ID | 00840682147255 |
| NIH Device Record Key | 375c6053-254b-4e77-baea-149c48d37dda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruSignal SpO2 |
| Version Model Number | TS-RWL-24 |
| Catalog Number | TS-RWL-24 |
| Company DUNS | 809785715 |
| Company Name | GE MEDICAL SYSTEMS, 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682147255 [Primary] |
| DPZ | Oximeter, ear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-13 |
| Device Publish Date | 2021-09-03 |
| 00840682147316 | Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs |
| 00840682147309 | Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs |
| 00840682147293 | Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs |
| 00840682147286 | Replacement Headband for TruSignal Ear sensor, 3 pcs |
| 00840682147279 | Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs |
| 00840682147262 | Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs |
| 00840682147255 | Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs |
| 00840682147248 | Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs |