Syringe, 10 mL E01P3

GUDID 16286780610023

The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

Front Line Medical Technologies Inc.

General-purpose syringe, single-use

• Primary Device ID: 16286780610023
• NIH Device Record Key: 4d2e4516-796e-435e-9a7f-10a53ece5bfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringe, 10 mL
• Version Model Number: E01P3
• Catalog Number: E01P3
• Company DUNS: 242512799
• Company Name: Front Line Medical Technologies Inc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	16286780610023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201652

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [Syringe, 10 mL]

• 16286780610023: The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™
• 10628678061023: The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™
• 10628678061061: The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™