FDA.reportPublic FDA data

Elite Balance Air Mattress

Primary DI
00851675007166
Brand
Elite Balance Air Mattress
Company
CORK MEDICAL, LLC
Model
6406-8
Device description
"Elite Balance Air HD Mattress (42"")"
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851675007166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851675007166008516750071668516750071660851675007166

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
015964214
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851675007388Nisus ONE NPWT System OCMPP-1002026-04-21
00851675007395100ml CanisterCPC-1002025-05-15
00851675007401VERSA NPWT SystemVCMPP-1002025-05-15
00851675007265Nisus Touch NPWT SystemTCMPP-1002022-12-19
00851675007005Nisus NPWT SystemCMPP-1002016-09-02
00851675007012Nisus NPWT Wound KitWDK-3002016-09-02
00851675007029Nisus NPWT Wound KitWDK-4002016-09-02
00851675007036Nisus NPWT AccessoryCWD-2002016-09-02
00851675007043Nisus NPWT AccessoryCWD-100-GS2016-09-02
00851675007050Nisus NPWT AccessoryCWF-100-ES-B2016-09-02
00851675007067Nisus NPWT AccessoryCWF-200-ES-B2016-09-02
00851675007074Nisus NPWT AccessoryCSP-100-ES-B2016-09-02
00851675007081Nisus NPWT AccessoryCSP-100-ES-EXT 2016-09-02
00851675007098Nisus NPWT SystemCPC-2502016-09-02
00851675007104Nisus NPWT SystemCPC-500 2016-09-02
00851675007128Nisus NPWT AccessoryCWY-1002016-09-02
00851675007135Nisus NPWT SystemNIS-CHRG-B-162016-09-02
00851675007203Nisus NPWT Wound KitFM-1.25-5-8-A-162016-11-09
00851675007210Nisus NPWT Wound KitWDK300T2016-11-09
00851675007227Nisus NPWT Wound KitWDK-2502016-11-09

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Primary DI, Brand, Company table
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00810055885695DOLPHIN FIS 48X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885701SYSTEM, DLPH PEDIATRIC CRIB, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMJOERNS HEALTHCARE, LLCFNM2026-08-26
00810226442016ViveVIVE HEALTH LLCFNM2026-08-19
00810226442023ViveVIVE HEALTH LLCFNM2026-08-19
00810226442030ViveVIVE HEALTH LLCFNM2026-08-19
00850076421106ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421113ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421120ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421137ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
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00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
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