AccessGUDID - DEVICE: Mor-Medical New Era (00850010988764)

GUDID

Device Identifier (DI) Information

Brand Name: Mor-Medical New Era
Version or Model: DNE-SG10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Moroles Investments, LLC

Primary DI Number: 00850010988764
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045103307 *Terms of Use

Device Description: Deluxe New Era Patented Infection Control Soft Touch Shower Gurney with Elevated Head Section, 450 lbs. wt. capacity

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:	No
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?
31092	Bathing stretcher	A manually-operated device consisting of a platform mounted on a frame designed to support a recumbent patient for bathing. It is designed to be submerged in an appropriate bath. The device is used primarily for a patient incapable of supporting themself in an upright position for bathing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	Stretcher, Wheeled

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: c7ec5d4d-90cf-443d-b8cd-23fa0906c8cf
Public Version Date: July 25, 2024
Public Version Number: 1
DI Record Publish Date: July 17, 2024