AccessGUDID - DEVICE: ICP (00813360021635)

GUDID

Device Identifier (DI) Information

Brand Name: ICP
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ICP-9003GUR
Company Name: ICP MEDICAL, LLC

Primary DI Number: 00813360021635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078780963 *Terms of Use

Device Description: Stretcher Sheet, White, 105x50

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37455	Waterproof bed mattress cover, reusable	A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMW	Cover, Mattress (Medical Purposes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 105 Inch
Width: 50 Inch

Device Record Status

Public Device Record Key: 4ae9fc18-2fe2-4a61-a0f3-cf838d8d7d01
Public Version Date: November 10, 2022
Public Version Number: 2
DI Record Publish Date: December 28, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10813360021632	10	00813360021635		In Commercial Distribution	Bag
30813360021629	10	10813360021632		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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