ICP ICP-9001GUR

GUDID 10813360021625

Universal Mattress Cover

ICP MEDICAL, LLC

Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable Waterproof bed mattress cover, reusable 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

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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