| Primary Device ID | 10816317023994 |
| NIH Device Record Key | df3eb28c-ea06-4fc7-905f-7f9ffce0fb89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nellcor Pulse Oximeter Probe |
| Version Model Number | RM-MAX-P |
| Company DUNS | 100439103 |
| Company Name | RENU MEDICAL, 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 | true |
| Lot Batch | false |
| Serial Number | false |
| 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 | 00816317023997 [Primary] |
| GS1 | 10816317023994 [Package] Contains: 00816317023997 Package: Case [24 Units] In Commercial Distribution |
| NLF | Oximeter, Reprocessed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-16 |
| Device Publish Date | 2025-07-08 |
| 10861317020566 | Nellcor OxiMax MAX-N NEONATAL/ADULT |
| 10861317020559 | Nellcor OxiMax MAX-I INFANT |
| 10861317020542 | Nellcor OxiMax MAX-AL ADULT |
| 10861317020535 | Nellcor OxiMax MAX-A ADULT |
| 10861317020528 | Nellcor Oxisensor D-25 |
| 10816317020566 | Nellcor OxiMax MAX-N NEONATAL/ADULT |
| 10816317020559 | Nellcor OxiMax MAX-I INFANT |
| 10816317020542 | Nellcor OxiMax MAX-AL ADULT |
| 10816317020535 | Nellcor OxiMax MAX-A ADULT |
| 10816317020528 | Nellcor Oxisensor D-25 |
| 10816317023994 | Nellcor OxiMax MAX-P PEDIATRIC |