AccessGUDID - DEVICE: Foxtrot Litter DA, with ACU Carrier (00818630010562)

GUDID

Device Identifier (DI) Information

Brand Name: Foxtrot Litter DA, with ACU Carrier
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F-LITC-DA-A
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00818630010562
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: The Foxtrot® DA provides the same compact versatile function as the original Foxtrot® Litter with an alternate strap method. With color coded side release buckles, the Foxtrot® DA is lightning fast for high-risk casualty extractions.

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?
13818	Portable stretcher	A manual device in the form of a portable lightweight platform or sheet with handles on which a patient can be carried in an emergency from an area inaccessible to a conventional ambulance stretcher. It may be designed as a folding stretcher, rescue backet, spine board, or evacuation sheet, and may include patient straps to secure/stabilize the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPP	Stretcher, Hand-Carried

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: 0f9b6639-fcbc-4021-8b38-9385b9b6213f
Public Version Date: May 16, 2024
Public Version Number: 2
DI Record Publish Date: October 21, 2020