AccessGUDID - DEVICE: FareTec PST (B54122210240)

GUDID

Device Identifier (DI) Information

Brand Name: FareTec PST
Version or Model: Civilian
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2221024
Company Name: FARETEC, INC.

Primary DI Number: B54122210240
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626802540 *Terms of Use

Device Description: FareTec PST, Civilian, orange, soft case.

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
FPO	Stretcher, Wheeled
FMR	Device, Transfer, Patient, Manual

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: f4811c3e-5bd2-4dbf-86df-12b79a3d3e47
Public Version Date: December 28, 2022
Public Version Number: 2
DI Record Publish Date: August 31, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 4403509510
Email: colleen@faretec.com

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