Primary Device ID | 04719873698332 |
NIH Device Record Key | 28e7a44d-5eb9-46f8-832a-2e28b77a4347 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | S2109-3011 |
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 | 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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04719873698332 [Primary] |
FNM | Mattress, Air Flotation, Alternating Pressure |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-28 |
Device Publish Date | 2025-08-20 |
04719873698424 - NA | 2025-09-17 CariChair Carry Bag(single-layer) |
04719873698431 - NA | 2025-09-17 Dual GT M-set 85 x 200cm VTX Carilex |
14719873698445 - NA | 2025-09-17 Dual GT Cover 85 x 200cm VTX Carilex-1p |
14719873695741 - NA | 2025-09-15 VT Instill Port Set Kit |
14719873695987 - NA | 2025-09-15 VT NX Port Set Kit |
14719873698216 - NA | 2025-08-28 CariRaise Cover 20" x 75" TDX Carilex-1p |
04719873698332 - NA | 2025-08-28AVA Cure P.U. US Carilex |
04719873698332 - NA | 2025-08-28 AVA Cure P.U. US Carilex |
04719873698349 - NA | 2025-08-28 AVA Cure M-set 36'' × 80'' TDX Carilex |