FDA.reportPublic FDA data

NA

Primary DI
04719873698189
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S5001-0021
Device description
CariRaise SYS US Carilex (R type)
Published
2025-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873698189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873698189047198736981894719873698189

GMDN Terms#

Term, Definition table
TermDefinition
Electrical assistive bedA mains electricity (AC-powered) bed designed for a person with a disability and operated by the occupant and/or an attendant using controls that activate electrically-powered motors that adjust the positioning of the mattress. It may have one or more sections of the mattress support platform that can be adjusted in height and/or angle.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658863238
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873698622NAS2003-A3002025-12-22
04719873698639NAS2003-A3102025-12-22
04719873698608NAS2003-22502025-12-22
04719873698615NAS2003-22602025-12-22
14719873698629NAS2003-A3002025-12-22
14719873698636NAS2003-A3102025-12-22
04713616090230NAS1001-20502018-12-05
04713616090247NAS1001-20602018-11-28
04713616091336NAS1001-21002021-03-16
04713616091350NAS1001-21302018-06-12
04713616091381NAS1001-21402018-06-12
04713616091411NAS1001-21502018-06-12
04713616092906NAS1001-20202018-06-12
04713616092913NAS1001-20302018-06-12
04713616094597NAS1001-81602021-03-16
04713616094627NAS1001-82002021-03-16
04719873691241NAS1001-21202018-12-05
04719873694938NAS1001-21602020-12-18
04719873694969NAS1001-21702020-12-14
04719873694990NAS1001-21802020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344215454MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215461MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215478MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344176618MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-16
10197344176601MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-13
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00841447116295Invacare® Bed Extender HeadspringINVACARE CORPORATIONLLI2025-12-05
05060631842580Cosyfit standard/Extra WideSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-21
05060631840036Siesta SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840166Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840173Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840180Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840364Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841101Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841194Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841200Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631842610Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843082Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843099Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843105Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843129Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843136Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843143Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840104Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840111Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840128Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840210Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840227Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12