FDA.reportPublic FDA data

NA

Primary DI
04713616091015
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S2001-2420
Device description
"TheraFlo M-set 35.5"" × 83"" AirBag QLT FMP"
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure
IOQBed, Flotation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713616091015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713616091015047136160910154713616091015

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.

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
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00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-4 D3XKAP MEDICALFNM2026-05-29
00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
08592654470589Multicare XL I N E T spol. s r.o.IOQ2025-01-17
08592654473467Multicare XL I N E T spol. s r.o.IOQ2025-01-17
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000001MatrixMidtown Investments, LLCFNM2023-01-27
00190885000018MatrixMidtown Investments, LLCFNM2023-01-27
00190885000025MatrixMidtown Investments, LLCFNM2023-01-27
H933PR13022Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
H933PR13444Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
H933PR13555Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
H933PR13601Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
H933PR13606Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
H933PR13607Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
H933PR13613Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2023-01-17
00092237623824PanaceaDrive Devilbiss HealthcareFNM2022-09-30
H933PT85V0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2022-07-06
H933LM7842XL29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2022-05-18