AccessGUDID - DEVICE: Mattress Sheet for Neo Cot(5 pcs/pkg) (04942962261227)

GUDID

Device Identifier (DI) Information

Brand Name: Mattress Sheet for Neo Cot(5 pcs/pkg)
Version or Model: 26122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 26122
Company Name: ATOM MEDICAL CORPORATION

Primary DI Number: 04942962261227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 690632047 *Terms of Use

Device Description: No description.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Bed sheet, single-use	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under). It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

FDA Product Code

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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
No Device Sizes

Device Record Status

Public Device Record Key: 1d5651ef-8dea-4637-bc43-72dbd11ed396
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 28, 2016