SAM(R) Junctional Tourniquet

GUDID 10822045000145

SJT Belt with 2 TCDs, Auxiliary Strap, Extender & Hand Pump

SAM Medical Products

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• Primary Device ID: 10822045000145
• NIH Device Record Key: 6fad6f46-1105-4268-8e51-263ffcfdacf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM(R) Junctional Tourniquet
• Version Model Number: SJT102D
• 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: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com
• Phone: 503-639-5474
• Email: customerservice@sammedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822045000148 [Primary]
GS1	10822045000145 [Package]; Contains: 00822045000148; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-28
• Device Publish Date: 2016-10-01

On-Brand Devices [SAM(R) Junctional Tourniquet]

• 10822045000152: SJT102T - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag labeled as Trainer
• 10822045000145: SJT Belt with 2 TCDs, Auxiliary Strap, Extender & Hand Pump
• 00822045000131: SAM Junctional Tourniquet - Bag
• 00822045000124: SAM Junctional Tourniquet - Auxiliary Strap
• 00822045000117: SAM Junctional Tourniquet - Extender
• 00822045000100: SAM Junctional Tourniquet - Hand Pump
• 00822045000087: SAM Junctional Tourniquet - TCD & Hand Pump
• 00822045000070: SAM Junctional Tourniquet - SJT Belt Only
• 00822045000063: SAM Junctional Tourniquet - SJT Belt with TCD, Hand Pump & Bag
• 00822045000056: SAM Junctional Tourniquet - SJT Belt with 2 TCDs, Auxiliary Strap, Extender, Hand Pump & Bag