| Primary Device ID | 04713616091343 |
| NIH Device Record Key | 5973f6b7-5ca5-4a0b-8b63-bb33f4219ff6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S1001-2100 |
| 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 | 04713616091336 [Primary] |
| GS1 | 04713616091343 [Package] Contains: 04713616091336 Package: [10 Units] In Commercial Distribution |
| GS1 | 04719873691210 [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 |
| 04719873696901 - NA | 2024-06-28 TheraFlo 9 M-set 36" x 80" WDTX Carilex |
| 14719873696915 - NA | 2024-06-28 TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p |
| 04719873696925 - NA | 2024-06-28 TheraFlo 9 M-set 42" x 80" DTX Carilex |
| 14719873696939 - NA | 2024-06-28 TheraFlo 9 Cover 42" x 80" DTX Carilex-1p |
| 04719873696949 - NA | 2024-06-28 FIT M-Set 36" x 80" VTX Carilex |
| 04719873696956 - NA | 2024-06-28 FIT M-Set 36" x 80" WDTX Carilex |
| 04719873696963 - NA | 2024-06-28 FIT M-set 36" x 80" QLT Carilex |
| 04719873696970 - NA | 2024-06-28 FIT M-Set 42" x 80" VTX Carilex |