FDA.reportPublic FDA data

The Völkner® Turning System

Primary DI
00853360007024
Brand
The Völkner® Turning System
Company
JAMES CONSOLIDATED, INC.
Model
MARK I Mattress Overlay
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
00853360007024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853360007024008533600070248533600070240853360007024

GMDN Terms#

Term, Definition table
TermDefinition
Low-air-loss bedA mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.

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
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
00853360007079The Völkner® Turning System"PANDA III 54"" 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
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
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
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
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
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
00190885000001MatrixMidtown Investments, LLCFNM2023-01-27
00190885000018MatrixMidtown Investments, LLCFNM2023-01-27
00190885000025MatrixMidtown Investments, LLCFNM2023-01-27