| Primary Device ID | 04713616090087 |
| NIH Device Record Key | d1bd62da-6059-437f-aa7d-b6251b062b35 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S1001-6010 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04713616090087 [Package] Contains: 04713616093606 Package: [5 Units] In Commercial Distribution |
| GS1 | 04713616093606 [Primary] |
| GS1 | 04713616094696 [Package] Package: [9 Units] In Commercial Distribution |
| KDQ | Bottle, Collection, Vacuum |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-31 |
| Device Publish Date | 2017-03-22 |
| 04719873691296 - NA | 2024-04-30 VT•200-i SYS Global Carilex |
| 04719873695898 - NA | 2024-04-30 VT•200-i NX SYS Global Carilex |
| 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 |