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The Völkner® Turning System

FDA UDI

Class II (US FDA UDI)

by James Consolidated, Inc.

Identity

Trade Name
The Völkner® Turning System FDA UDI
Generic Name
Low-air-loss bed FDA UDI
Model / Reference
BETA II Mattress Replacement FDA UDI

Identifiers

Primary DI / UDI-DI
00853360007017 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Low-air-loss bed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Low-air-loss bedAlternating-pressure inflator

The Völkner® Turning System by James Consolidated, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alternating-pressure inflator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
James Consolidated, Inc.

Sources (1)

  • FDA UDI 4a1b42e0-da7e-4274-b914-6ca22c8fb919 32 fields · synced May 30, 2026