AccessGUDID - DEVICE: Medegen Medical Products, LLC (00700812003724)

GUDID

Device Identifier (DI) Information

Brand Name: Medegen Medical Products, LLC
Version or Model: 2230PP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDEGEN MEDICAL PRODUCTS, LLC

Primary DI Number: 00700812003724
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 055527753 *Terms of Use

Device Description: Pillow Case: 22X30 Paper/Poly 100/cs

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":	Yes
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?
37456	Pillow cover, single-use	A device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. This is a single-use device.	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: 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: 2f4722c0-6db0-408e-a11e-b3323a670bad
Public Version Date: December 28, 2020
Public Version Number: 1
DI Record Publish Date: December 20, 2020