AccessGUDID - DEVICE: Abdominal Aortic & Junctional Tourniquet (Stabilized)

GUDID

Device Identifier (DI) Information

Brand Name: Abdominal Aortic & Junctional Tourniquet (Stabilized) - AAJT-S
Version or Model: AAJT-S001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Compression Works, Inc.

Primary DI Number: 00860002227504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112559979 *Terms of Use

Device Description: Abdominal Aortic & Junctional Tourniquet (Stabilized) - AAJT-S

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:	Yes
Prescription Use (Rx):	Yes
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?
63268	Emergency junctional haemorrhage compression set	A collection of non-sterile, noninvasive devices intended to be used in an emergency situation (e.g., battlefield) to provide compression for haemostasis to a traumatic wound occurring proximal to where a limb meets the torso/pelvis. Often referred to as a junctional tourniquet, it consists of a belt(s)/binder(s), an inflatable bulb(s), and a hand pump. The inflatable bulb is intended to be secured at the point of the wound with the belt, then inflated to provide compression and prevent bleeding. The belt component may be additionally intended to be used as a binder. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221661	000

Device Exempt from Premarket Submission: No 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: 65dc4877-c50b-425a-903f-01b2aae9e5b8
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: March 20, 2023