FDA.reportPublic FDA data

NA

Primary DI
04713616096362
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S2001-A780
Device description
"TheraFlo 7 & 9 Cover 36"" x 80"" VTX Carilex-1p"
Published
2022-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOQBed, Flotation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713616096379PackageGS110Not in Commercial Distribution
14713616096369PackageGS110In Commercial Distribution
04713616096362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713616096379047136160963794713616096379
1471361609636914713616096369
04713616096362047136160963624713616096362

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Regulatory Flags#

DUNS number
658863238
Device count
1
Premarket exempt
true
Lot or batch
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

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