ICP ICP-9001GUR

GUDID 10813360021625

Universal Mattress Cover

ICP MEDICAL, LLC

Waterproof bed mattress cover, reusable

• Primary Device ID: 10813360021625
• NIH Device Record Key: be790b79-36ca-420d-9f63-04a67667fb82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICP
• Version Model Number: 1
• Catalog Number: ICP-9001GUR
• Company DUNS: 078780963
• Company Name: ICP MEDICAL, LLC
• 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: true
• Lot Batch: true
• 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 Dimensions

• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch
• Length: 96 Inch
• Width: 37 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813360021628 [Primary]
GS1	10813360021625 [Package]; Contains: 00813360021628; Package: Bag [10 Units]; In Commercial Distribution
GS1	20813360021622 [Package]; Package: Case [10 Units]; In Commercial Distribution

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: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [ICP]

• 00813360021499: 30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist
• 00813360021482: 30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist
• 10813360021625: Universal Mattress Cover
• 10813360021632: 2XXL White Universal Mattress Cover
• 00688162000481: Stretcher Sheet, White, SMS 108x51
• 10688162000464: Stretcher Sheet, White, SMS 96x37