JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®) 30-0088

GUDID 00842209100002

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®) For treating high extremity wounds in the thigh/groin region at or near point of injury, includes two pressure devices in a single tool, allowing for simultaneous occlusion of blood flow to both lower limbs (bilateral) with an easy to apply, pre-assembled, ready-to-use belt solution Single use.

NORTH AMERICAN RESCUE, LLC

Arm/leg tourniquet, single-use

• Primary Device ID: 00842209100002
• NIH Device Record Key: 761754ea-20a2-4409-b24b-e768911b3633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT®)
• Version Model Number: 30-0088
• Catalog Number: 30-0088
• Company DUNS: 832426782
• Company Name: NORTH AMERICAN RESCUE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842209100002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123194

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: 5
• Public Version Date: 2019-08-26
• Device Publish Date: 2016-09-17

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