FDA.reportPublic FDA data

The Völkner® Turning System

Primary DI
00853360007079
Brand
The Völkner® Turning System
Company
JAMES CONSOLIDATED, INC.
Model
"PANDA III 54"" Bariatric Mattress Replacement"
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
00853360007079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853360007079008533600070798533600070790853360007079

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

Regulatory Flags#

DUNS number
183085083
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853360007000The Völkner® Turning SystemBETA I Mattress Overlay2016-11-18
00853360007017The Völkner® Turning SystemBETA II Mattress Replacement2016-11-18
00853360007024The Völkner® Turning SystemMARK I Mattress Overlay2016-11-18
00853360007031The Völkner® Turning SystemMARK II Mattress Replacement2016-11-18
00853360007048The Völkner® Turning SystemEUROPA I Mattress Overlay2016-11-18
00853360007062The Völkner® Turning System"PANDA III 48"" Bariatric Mattress Replacement"2016-11-18
00853360007086The Völkner® Turning System"BETA I Mattress Overlay 84"" Special Production"2016-11-18
00853360007093The Völkner® Turning System"BETA II Mattress Replacement 84"" Special Product2016-11-18
00853360007109The Völkner® Turning System"EUROPA I Mattress Overlay 84"" Special Production2016-11-18
00853360007116The Völkner® Turning System"MARK I Mattress Overlay 84"" Special Production"2016-11-18
00853360007123The Völkner® Turning System"MARK II Mattress Replacement 84"" Special Produc2016-11-18
00853360007130The Völkner® Turning System"PANDA III 48"" Bariatric Mattress Replacement 842016-11-18
00853360007147The Völkner® Turning System"PANDA III 54"" Bariatric Mattress Replacement 842016-11-18

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