SAM® Junctional Tourniquet

GUDID 10822045000398

SAM Junctional Tourniquet - Belt

SAM Medical Products

Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set Emergency junctional haemorrhage compression set

• Primary Device ID: 10822045000398
• NIH Device Record Key: 85243f0f-ef86-457a-bb40-f46c644098ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM® Junctional Tourniquet
• Version Model Number: JT403-EN
• Company DUNS: 131084188
• Company Name: SAM Medical Products
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822045000070 [Previous]
GS1	00822045000391 [Primary]
GS1	10822045000398 [Package]; Contains: 00822045000391; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131561

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-09
• Device Publish Date: 2020-04-01

On-Brand Devices [SAM® Junctional Tourniquet]

• 10822045000367: SAM Junctional Tourniquet - SJT Belt with TCD, Hand Pump & Bag
• 10822045000350: SAM Junctional Tourniquet - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag
• 10822045000343: SAM Junctional Tourniquet Trainer - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump &
• 10822045000398: SAM Junctional Tourniquet - Belt