THE KREG INTEGRATED CLRT MATTRESS SYSTEM

GUDID 00861525000414

Hospital Bed Surface

KREG MEDICAL INC.

Low-air-loss bed

• Primary Device ID: 00861525000414
• NIH Device Record Key: c1442b61-3577-4847-a7a7-93fb230bd7cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THE KREG INTEGRATED CLRT MATTRESS SYSTEM
• Version Model Number: ASM100202
• Company DUNS: 079220324
• Company Name: KREG MEDICAL 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: true
• 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: (866) 760-5734
• Email: kmiudiInfo@kreg.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861525000414 [Primary]

FDA Product Code

• IKZ: Bed, Patient Rotation, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-21

On-Brand Devices [THE KREG INTEGRATED CLRT MATTRESS SYSTEM]

• 00861525000414: Hospital Bed Surface
• 00850520008150: Hospital Bed Surface
• 00850520008037: Hospital Bed Surface