| Primary Device ID | 10840828186008 |
| NIH Device Record Key | 1b2dfc27-05de-431e-9ea3-a0e9c943fe84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISP NK COMP SPO2 SNSR,TL-272T,PDTRC,39",CLR FLM,NON-STRL,EACH |
| Version Model Number | CSA027DP-P100 |
| Catalog Number | 28175 |
| Company DUNS | 796452311 |
| Company Name | CURBELL MEDICAL PRODUCTS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00840828186001 [Primary] |
| GS1 | 00840828189583 [Package] Contains: 00840828186001 Package: Case [24 Units] In Commercial Distribution |
| GS1 | 10840828186008 [Package] Contains: 00840828186001 Package: Case [30 Units] In Commercial Distribution |
| DQA | Oximeter |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-07 |
| Device Publish Date | 2023-07-28 |
| 00840828193733 - GEN4 DIRECT ACCESS | 2025-01-16 |
| 00840828193740 - GEN4 DIRECT ACCESS | 2025-01-16 |
| 00840828193757 - GEN4 DIRECT ACCESS | 2025-01-16 |
| 00840828193764 - GEN4 DIRECT ACCESS | 2025-01-16 |
| 00840828193771 - GEN4 INTERACTIVE | 2025-01-16 |
| 00840828193788 - GEN4 INTERACTIVE | 2025-01-16 |
| 00840828193795 - GEN4 INTERACTIVE | 2025-01-16 |
| 00840828193801 - GEN4 PLUS, DIRECT ACCESS | 2025-01-16 |