| Primary Device ID | 04713616091428 |
| NIH Device Record Key | d8d2c687-3eda-431d-a566-5ef165a872c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S1001-2150 |
| 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 | 04713616091411 [Primary] |
| GS1 | 04713616091428 [Package] Contains: 04713616091435 Package: [15 Units] In Commercial Distribution |
| GS1 | 04713616091435 [Package] Contains: 04713616091411 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2018-06-12 |
| 04719873696857 - NA | 2023-12-12 VT•200 P.U. Global Med One |
| 04719873696864 - NA | 2023-12-12 VT•200 SYS Global Med One |
| 14713616094785 - NA | 2023-09-18 Envelop Cover 42'' × 80'' QLT-1p |
| 04713616094764 - NA | 2023-09-06 Envelop M-set 42'' × 80'' QLT Carilex |
| 04719873692972 - NA | 2022-08-23 TheraFlo 9 M-set 90 x 200cm WDTX Carilex |
| 00471987369297 - NA | 2022-08-01 TheraFlo 9 M-set 90 x 200cm WDTX Carilex |
| 04719873692989 - NA | 2022-08-01 TheraFlo 9 M-set 107 x 200cm DTX Carilex |
| 04719873693108 - NA | 2022-08-01 TheraFlo 7 & 9 Cover 90 x 200cm WDTX Carilex-1p |