| Primary Device ID | 14719873698216 |
| NIH Device Record Key | b8e23c1c-ac0d-42ff-99a6-749c69a36876 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S2106-A010 |
| 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 | 04719873698219 [Primary] |
| GS1 | 14719873698216 [Package] Contains: 04719873698219 Package: [10 Units] In Commercial Distribution |
| FNM | Mattress, Air Flotation, Alternating Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-28 |
| Device Publish Date | 2025-08-20 |
| 04719873698424 - NA | 2025-09-17 CariChair Carry Bag(single-layer) |
| 04719873698431 - NA | 2025-09-17 Dual GT M-set 85 x 200cm VTX Carilex |
| 14719873698445 - NA | 2025-09-17 Dual GT Cover 85 x 200cm VTX Carilex-1p |
| 14719873695741 - NA | 2025-09-15 VT Instill Port Set Kit |
| 14719873695987 - NA | 2025-09-15 VT NX Port Set Kit |
| 14719873698216 - NA | 2025-08-28CariRaise Cover 20" x 75" TDX Carilex-1p |
| 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 |