AccessGUDID - DEVICE: FareTec Wheeled Litter Carrier (B54122210800)

GUDID

Device Identifier (DI) Information

Brand Name: FareTec Wheeled Litter Carrier
Version or Model: Bariatric Litter Carrier
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2221080
Company Name: FARETEC, INC.

Primary DI Number: B54122210800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626802540 *Terms of Use

Device Description: NATO WLC with bariatric frame

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?
64999	Stretcher all-terrain wheeled undercarriage	A non-powered, manually-operated (hand-pushed) undercarriage consisting of a heavy-duty frame with large wheels designed to accept a patient stretcher/board (not included) on its top and intended to facilitate transport of a recumbent patient by emergency medical services, primarily over difficult terrain inaccessible to conventional ambulance stretchers (e.g., off-road, mountain sites), typically to and from ambulances, emergency shelters, and mobile hospitals. It is constructed of sturdy materials, includes locks/clamps for securing the stretcher, and is foldable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMR	Device, Transfer, Patient, Manual
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: aaa58584-408c-4be5-9c59-9ded7100a5cb
Public Version Date: May 09, 2023
Public Version Number: 1
DI Record Publish Date: May 01, 2023