| Primary Device ID | 04713616094603 |
| NIH Device Record Key | 85d3c7d8-ec21-4c57-8b72-97d0d089c2d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S1001-8160 |
| 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 | 04713616094597 [Primary] |
| GS1 | 04713616094603 [Package] Contains: 04713616094597 Package: [15 Units] In Commercial Distribution |
| GS1 | 04713616094610 [Package] Package: [5 Units] In Commercial Distribution |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-24 |
| Device Publish Date | 2021-03-16 |
| 14719873698216 - NA | 2025-08-28 CariRaise Cover 20" x 75" TDX Carilex-1p |
| 04719873698332 - NA | 2025-08-28 AVA Cure P.U. US Carilex |
| 04719873698349 - NA | 2025-08-28 AVA Cure M-set 36'' × 80'' TDX Carilex |
| 04719873698356 - NA | 2025-08-28 AVA Cure M-set 42'' × 80'' TDX Carilex |
| 04719873698363 - NA | 2025-08-28 AVA Cure M-set 36'' × 84'' TDX Carilex |
| 04719873698370 - NA | 2025-08-28 AVA Cure M-set 42'' × 84'' TDX Carilex |
| 14719873698384 - NA | 2025-08-28 AVA Cure Cover 36'' × 80'' TDX Carilex-1p |
| 14719873698391 - NA | 2025-08-28 AVA Cure Cover 42'' × 80'' TDX Carilex-1p |