The Völkner® Turning System

GUDID 00853360007147

JAMES CONSOLIDATED, INC.

Low-air-loss bed
Primary Device ID00853360007147
NIH Device Record Key4fcfd316-4aa6-4c96-adaf-33e2ec03bd87
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Völkner® Turning System
Version Model NumberPANDA III 54" Bariatric Mattress Replacement 84"
Company DUNS183085083
Company NameJAMES CONSOLIDATED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853360007147 [Primary]

FDA Product Code

FNMMattress, Air Flotation, Alternating Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-01
Device Publish Date2016-11-18

On-Brand Devices [The Völkner® Turning System]

00853360007147PANDA III 54" Bariatric Mattress Replacement 84"
00853360007130PANDA III 48" Bariatric Mattress Replacement 84"
00853360007123MARK II Mattress Replacement 84" Special Producti
00853360007116MARK I Mattress Overlay 84" Special Production
00853360007109EUROPA I Mattress Overlay 84" Special Production
00853360007093BETA II Mattress Replacement 84" Special Productio
00853360007086BETA I Mattress Overlay 84" Special Production
00853360007079PANDA III 54" Bariatric Mattress Replacement
00853360007062PANDA III 48" Bariatric Mattress Replacement
00853360007048EUROPA I Mattress Overlay
00853360007031MARK II Mattress Replacement
00853360007024MARK I Mattress Overlay
00853360007017BETA II Mattress Replacement
00853360007000BETA I Mattress Overlay

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