| Primary Device ID | 04713616092890 |
| NIH Device Record Key | 0a69ff8f-2560-4910-8963-de2cadee7c58 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S1001-2010 |
| Company DUNS | 658863238 |
| Company Name | CARILEX 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 | true |
| 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 | 04713616090056 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 04713616091466 [Package] Contains: 04713616090056 Package: [10 Units] In Commercial Distribution |
| GS1 | 04713616092890 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2018-06-12 |
| 04719873698608 - NA | 2025-12-30 Envelop M-set 42" x 80" VTX Carilex |
| 04719873698615 - NA | 2025-12-30 Envelop M-set 48" x 80" VTX Carilex |
| 14719873698629 - NA | 2025-12-30 Envelop Cover 42" x 80" VTX Carilex-1p |
| 14719873698636 - NA | 2025-12-30 Envelop Cover 48" x 80" VTX Carilex-1p |
| 04719873693634 - NA | 2025-12-29 VT Drape and Port Set Kit S Lock |
| 04719873693641 - NA | 2025-12-29 VT Drape and Port Set Kit M Lock |
| 04719873693658 - NA | 2025-12-29 VT Drape and Port Set Kit L Lock |
| 04719873698424 - NA | 2025-09-17 CariChair Carry Bag(single-layer) |