COVERLET WITH ZIPPER

GUDID 00850520008211

Silver Coverlet with Zipper

KREG MEDICAL INC.

Waterproof bed mattress cover, reusable

• Primary Device ID: 00850520008211
• NIH Device Record Key: e97dffca-3f14-4f30-a738-265e9965d887
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COVERLET WITH ZIPPER
• Version Model Number: ASM100118
• 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	00850520008211 [Primary]

FDA Product Code

• FMW: Cover, Mattress (Medical Purposes)

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 [COVERLET WITH ZIPPER]

• 00850520008211: Silver Coverlet with Zipper
• 00850520008204: Deep Purple Coverlet with Zipper