FDA.reportPublic FDA data

Dolphin Fluid Immersion Simulation

Primary DI
00857268006455
Brand
Dolphin Fluid Immersion Simulation
Company
JOERNS HEALTHCARE, LLC
Model
DLPH-4282LPOOJ-M
Catalog number
DLPH-4282LPOOJ-M
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00857268006455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857268006455008572680064558572680064550857268006455

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

Contacts#

Phone, Email table
PhoneEmail
800-826-0270xxx@xxx.xxx

Regulatory Flags#

DUNS number
790937150
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
00810055885695DOLPHIN FIS 48X82X10 AUTOVECTOR SYSTEM UKDLPH-4882OOUKJ-KIT2026-08-26
00810055885701SYSTEM, DLPH PEDIATRIC CRIB, UKDLPP-2850CBUKJ-KIT2026-08-26
00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKDLPH-3582OOUKJ-KIT2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKDLPP-3382OOUKJ-KIT2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMDLPH-3382OOUKJ-KIT2026-08-26
00810055885428SLING,QFIT PAD,SOLID,SMALLSL1000P-BV2026-08-25
00810055885435SLING,QFIT PAD,SOLID,MEDIUMSL1003P-BV2026-08-25
00810055885442SLING,QFIT,NET,MEDIUMSL1004-BV2026-08-25
00810055885459SLING,QFIT PAD,SOLID,LARGESL1006P-BV2026-08-25
00810055885466SLING,QFIT DLUX,SOLID,SMALLSL1050-BV2026-08-25
00810055885473SLING,QFIT DLUX,SOLID,MEDIUMSL1053-BV2026-08-25
00810055885480SLING,QFIT DLUX,NET,MEDIUMSL1054-BV2026-08-25
00810055885497SLING,QFIT DLUX,SOLID,LARGESL1056-BV2026-08-25
00810055885503SLING,QFIT DLUX,NET,LARGESL1057-BV2026-08-25
00810055885510SLING,L/S PLAIN,SOLID,SMALLSL1100-BV2026-08-25
00810055885527SLING,L/S PLAIN,NET,MEDIUMSL1104-BV2026-08-25
00810055885534SLING,STANDING DLUX,SOLID,LARGESL13498N-BV2026-08-25
00810055885541SLING,STANDING DLUX,SOLID,SMALLSL13499N-BV2026-08-25
00810055885558SLING,STANDING DLUX,SOLID,MEDIUMSL13500N-BV2026-08-25
00810055885565SLING,TRANSPORT DLUX,SOLID,MEDIUMSL13501N-BV2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H933M90068Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-09-25
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
H93359076Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-07-27
04719876192011TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-09
04719876190048TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190215TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190482TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190499TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876191991TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192004TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192202TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192219TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
00841447116745Invacare MA500X4280MINVACARE CORPORATIONFNM2026-07-01
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.FNM2026-06-09
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