DALTON LOW AIR LOSS MATTRESS SYSTEM

GUDID 00815027011782

LOW AIR LOSS XCELL MATTRESS SYSTEM, W/LOW PRESS CPC 5" x 20, WT. LIMIT 260 LBS.

DALTON MEDICAL CORPORATION

Air-filled bed mattress overlay

• Primary Device ID: 00815027011782
• NIH Device Record Key: 6c50e06f-4553-4a24-a72b-847146777a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DALTON LOW AIR LOSS MATTRESS SYSTEM
• Version Model Number: PM-XCELL5000V
• Company DUNS: 874709348
• Company Name: DALTON MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815027011782 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [DALTON LOW AIR LOSS MATTRESS SYSTEM]

• 00815027011928: DALTON LOW AIR LOSS MATTRESS SYSTEM 9" W/PUMP, WT. LIMIT 450 LBS.
• 00815027011782: LOW AIR LOSS XCELL MATTRESS SYSTEM, W/LOW PRESS CPC 5" x 20, WT. LIMIT 260 LBS.
• 00815027011775: LOW AIR LOSS MATTRESS SYSTEM 84", W/PUMP, 8" TUBE, WT. LIMIT 350 LBS.
• 00815027011348: LOW AIR LOSS MATTRESS SYSTEM, WITH PUMP, WT. LIMIT 350 LBS.