FDA.reportPublic FDA data

Dolphin Control Unit

Primary DI
00857268006523
Brand
Dolphin Control Unit
Company
JOERNS HEALTHCARE, LLC
Model
Dolphin Control Unit
Catalog number
DLPH-OOOOOODMU-CU
Published
2016-09-09
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
00857268006523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857268006523008572680065238572680065230857268006523

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure pumpA mains electricity (AC-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

Contacts#

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

Regulatory Flags#

DUNS number
790937150
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055880126SlingsNA25705NA257052025-07-22
00810055884865Dolphin Fluid Immersion SimulationDLPH-3382OOEUJ-MDLPH-3382OOEUJ-M2025-07-10
00857268006707Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2025-07-10
00857268006851Dolphin Fluid Immersion SimulationDLPH-4882LPOOJ-MDLPH-4882LPOOJ-M2025-07-10
00857268006875Dolphin Fluid Immersion SimulationDLPH-3582OO4WJ-MDLPH-3582OO4WJ-M2025-07-10
00857268006752Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-CDLPH-1717WCOOJ-C2025-07-08
00857268006295Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-MDLPH-3582OOOOJ-M2025-07-07
00857268006257Dolphin Fluid Immersion SimulationFIS Step-deckDLPH-3588OVOOJ-M2016-09-06
00857268006417Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-M2016-09-02
00810055884834Panacea - DSPAN1000-FLEX-RILG2PAN1000-FLEX-RILG22025-06-18
00810055884841Panacea - DSPAN1K-FLEX-RILG2QSPAN1K-FLEX-RILG2QS2025-06-18
00810055884858Panacea - DSPAN1000-FLEX-RAHG2PAN1000-FLEX-RAHG22025-06-18
00857268006868Dolphin FISDLPP-2850CBJ-MDLPP-2850CBJ-M2025-05-29
00857268006271Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-M2017-08-22
00857268006424Dolphin Fluid Immersion SimulationDLPH-3582LPOOOJ-MDLPH-3582LPOOOJ-M2016-09-02
00857268006714Dolphin Fluid Immersion SimulationDLPH-4882OOOOJ-M2017-08-22
00857268006318Dolphin Fluid Immersion SimulationDLPH-4282OOOOJ-M2017-08-22
00857268006394Dolphin Fluid Immersion SimulationFIS StretcherDLPH-3176OSOOJ-P2016-09-02
00857268006400Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-C2016-09-02
00857268006455Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884353ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
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
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28