FDA.reportPublic FDA data

Foam Products

Primary DI
00810055880324
Brand
Foam Products
Company
JOERNS HEALTHCARE, LLC
Model
8807EA
Device description
"7"" Donut positioner "
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810055880328PackageGS124In Commercial Distribution
00810055880324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081005588032820810055880328
00810055880324008100558803248100558803240810055880324

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.

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
00810055885831SLING, QUICKFIT, 6-PT, DELUXE NET, SM,BVSL1051-BV2026-10-23
00810055885770SCALE, LOW PROFILE UNIVERSAL, LIFTS USHOY-SCALE-LPU2026-10-22
00810055885787LOW PROFILE SCALE ASSEMBLY - NKP, US310097722026-10-22
00810055885794SCALE, LOW PROFILE UNIVERSAL, LIFTS EUJOE-SCALE-LPU-EU2026-10-22
00810055885800SCALE, LOW PROFILE UNIVERSAL, LIFTS UKOXF-SCALE-LPU2026-10-22
00810055885817KIT, SCALE HPL402 / HML400, 250KG390020502026-10-22
00810055885824KIT, SCALE ADVANCE, 250KG390020512026-10-22
00810055885749DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMDLPH-3382OOEUJ-KIT2026-10-06
00810055885756SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, EUDLPP-3382OOEUJ-KIT2026-10-06
00810055885763SYSTEM, DOLPHIN SYSTEM, AUDLPH-3582OOAUJ-KIT2026-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011510Action®ACTION PRODUCTS, INC.FMP2026-10-14
00089904011527Action®ACTION PRODUCTS, INC.FMP2026-10-14
00850018561037Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561044Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561051Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561068SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561075SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561082SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20