| Primary Device ID | 14719873696915 |
| NIH Device Record Key | 5924fc4a-d082-4891-b082-3f19969f30f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S2001-A880 |
| 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 | 04719873696918 [Primary] |
| GS1 | 14719873696915 [Package] Contains: 04719873696918 Package: [10 Units] In Commercial Distribution |
| IOQ | Bed, Flotation Therapy, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
| 04719873696901 - NA | 2024-06-28 TheraFlo 9 M-set 36" x 80" WDTX Carilex |
| 14719873696915 - NA | 2024-06-28TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p |
| 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 |