FDA.reportPublic FDA data

Dolphin

Primary DI
00810055880973
Brand
Dolphin
Company
JOERNS HEALTHCARE, LLC
Model
DLPH-OOOOOOSWJ-CU
Device description
CONTROL UNIT,DOLPHIN,SWISS,JOERNS
Published
2023-08-14
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055880973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055880973008100558809738100558809730810055880973

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure pumpAn electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790937150
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
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
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
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13