The Völkner® Turning System

GUDID 00853360007109

JAMES CONSOLIDATED, INC.

Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed Low-air-loss bed

• Primary Device ID: 00853360007109
• NIH Device Record Key: 00863336-c806-486c-b5ac-9bde7b352533
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Völkner® Turning System
• Version Model Number: EUROPA I Mattress Overlay 84" Special Production
• Company DUNS: 183085083
• Company Name: JAMES CONSOLIDATED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853360007109 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-01
• Device Publish Date: 2016-11-18

On-Brand Devices [The Völkner® Turning System]

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