Primary Device ID | 04719873696864 |
NIH Device Record Key | 04bade2f-9491-46b4-b468-57cd07eec983 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | S1002-0082 |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 | 04719873696864 [Primary] |
OMP | Negative Pressure Wound Therapy Powered Suction Pump |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-12 |
Device Publish Date | 2023-12-04 |
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 |