| Primary Device ID | 04713616093477 |
| NIH Device Record Key | 010d065c-5d2f-4c12-8a02-b4f32d9ab7c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S2204-A060 |
| Company DUNS | 658863238 |
| Company Name | CARILEX MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04713616092715 [Primary] |
| GS1 | 04713616093477 [Package] Contains: 04713616092715 Package: [10 Units] In Commercial Distribution |
| IMS | Support, Head And Trunk, Wheelchair |
| KIC | Cushion, Flotation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2017-03-22 |
| 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 |