GUDID 04719873698172

CariRaise SYS US Carilex (L type)

CARILEX MEDICAL, INC.

Electrical assistive bed
Primary Device ID04719873698172
NIH Device Record Key26d321dd-b2a4-48ec-a488-caf23d579cb4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS5001-0011
Company DUNS658863238
Company NameCARILEX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873698172 [Primary]

FDA Product Code

LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-27
Device Publish Date2025-06-19

Devices Manufactured by CARILEX MEDICAL, INC.

04719873698608 - NA2025-12-30 Envelop M-set 42" x 80" VTX Carilex
04719873698615 - NA2025-12-30 Envelop M-set 48" x 80" VTX Carilex
14719873698629 - NA2025-12-30 Envelop Cover 42" x 80" VTX Carilex-1p
14719873698636 - NA2025-12-30 Envelop Cover 48" x 80" VTX Carilex-1p
04719873693634 - NA2025-12-29 VT Drape and Port Set Kit S Lock
04719873693641 - NA2025-12-29 VT Drape and Port Set Kit M Lock
04719873693658 - NA2025-12-29 VT Drape and Port Set Kit L Lock
04719873698424 - NA2025-09-17 CariChair Carry Bag(single-layer)

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.