Burke 63187

GUDID B314631871

Foam Mattress w/ bolsters - 48"

BURKE, INC.

Orthopaedic bed mattress

• Primary Device ID: B314631871
• NIH Device Record Key: a8a16ee5-8b4c-4658-928c-f3e77fe2d750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burke
• Version Model Number: Bari-Float Mattress 48"
• Catalog Number: 63187
• Company DUNS: 045093101
• Company Name: BURKE, INC.
• 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: 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

Customer Support Contacts

• Phone: 913-722-5658
• Email: jernst@burke-mobility.com
• Phone: 913-722-5658
• Email: jernst@burke-mobility.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B314631871 [Primary]

FDA Product Code

• IKY: Mattress, Flotation Therapy, Non-Powered

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: 2016-09-01

On-Brand Devices [Burke]

• B314634101: Foam mattress 54" width
• B31463398B1: Bariatric Bed
• B314631871: Foam Mattress w/ bolsters - 48"