AccessGUDID - DEVICE: Covert Trauma Pouch Kit (TMK-CTP), Black w/SOFTT-W (00850018201001)

GUDID

Device Identifier (DI) Information

Brand Name: Covert Trauma Pouch Kit (TMK-CTP), Black w/SOFTT-W
Version or Model: 01328BK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01328BK
Company Name: Altitude Technologies Inc.

Primary DI Number: 00850018201001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621904622 *Terms of Use

Device Description: The Tactical Medical Kit - Covert Trauma Pouch (TMK-CTP) was designed to be small enough for everyday or discreet carry while still capable of holding all supplies necessary for TCCC recommended treatment.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHO	First Aid Kit Without Drug

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: 305bb545-a5ad-4b71-b4fd-32266ee5785f
Public Version Date: June 13, 2023
Public Version Number: 2
DI Record Publish Date: May 18, 2020