AccessGUDID - DEVICE: QA3 Patient Stretcher System (05051995000013)

GUDID

Device Identifier (DI) Information

Brand Name: QA3 Patient Stretcher System
Version or Model: QA3 Emergency Stretcher
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21120
Company Name: Anetic Aid USA LLC

Primary DI Number: 05051995000013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083649158 *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:	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?
15726	Radiographic stretcher	A manually-operated device consisting of a radiation translucent platform mounted on a wheeled frame designed to transport and support a recumbent patient during the acquisition of radiographic images. It may include various accessories (e.g., slots and cassette-support attachments). It is commonly used in emergencies to produce the first diagnostic images of a patient when there is little time for conventional protocol (e.g., in cases of serious patient trauma or during a large-scale catastrophe).	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: ece1cef2-95c6-434d-ae7b-01dd13e01f70
Public Version Date: September 19, 2023
Public Version Number: 1
DI Record Publish Date: September 11, 2023