AccessGUDID - DEVICE: Neo Sheets(100 pcs/box) (04942962603379)

GUDID

Device Identifier (DI) Information

Brand Name: Neo Sheets(100 pcs/box)
Version or Model: 60337
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60337
Company Name: ATOM MEDICAL CORPORATION

Primary DI Number: 04942962603379
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35180	Conductive bed mattress cover	A device made of soft, conductive material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination and the build-up of static electricity. This is a single-patient device that is used for a limited time, without laundering, until considered inappropriate for further use and then discarded (e.g., incinerated).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	Bedding, Disposable, Medical

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: Yes
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: 320da13e-d56e-465b-aba5-835611e5026e
Public Version Date: January 29, 2019
Public Version Number: 3
DI Record Publish Date: September 21, 2016