SAM® Junctional Tourniquet

Basic Information

• Brand Name: SAM® Junctional Tourniquet
• Primary DI: 00822045000353
• Version / Model: JT400-EN
• Company Name: SAM Medical Products
• Labeler DUNS: 131084188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-25
• Public Version: 3
• Public Version Date: 2021-07-28
• Public Version Status: Update
• Public Device Record Key: 9ee59c84-df5c-480c-a72d-2ac44d1b8e30

Device Description

SAM Junctional Tourniquet - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10822045000350	GS1	Case	6	In Commercial Distribution
Primary	00822045000353	GS1
Previous	00822045000056	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131561	000