Side Ported Needle

GUDID 00850007350031

Side Ported Needle (12/pk)

C2DX, INC.

Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use Compartmental-pressure monitoring system, single-use

• Primary Device ID: 00850007350031
• NIH Device Record Key: 729225fe-a833-4135-8a17-7ca7694b27f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Side Ported Needle
• Version Model Number: 0295-003-000
• Company DUNS: 116981210
• Company Name: C2DX, INC.
• Device Count: 12
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007350031 [Unit of Use]
GS1	10850007350038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844214

FDA Product Code

• LXC: Monitor, Pressure, Intracompartmental

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: 2020-04-16
• Device Publish Date: 2020-04-08

Devices Manufactured by C2DX, INC.

• 00850007350208 - HEMOSTATIX THERMAL SCALPEL SYSTEM: 2023-12-28 MODEL P8400 CONSOLE - QTY 1
• 00850007350222 - SHAW SCALPEL: 2023-12-28 FOOTSWITCH FOR P8400 CONSOLE
• 10850007350236 - SHAW SCALPEL: 2023-12-28 MODEL 8050 HANDLE - QTY 1
• 10850007350250 - SHAW SCALPEL: 2023-12-28 MODEL 9050 HANDLE - QTY 1
• 00850007350260 - SHAW SCALPEL: 2023-12-28 MODEL 5712 BLADE - QTY 10
• 00850007350215 - SHAW SCALPEL: 2023-12-28 MODEL 5710 BLADE - QTY 24
• 00850007350253 - SHAW SCALPEL: 2023-12-28 MODEL 9050 HANDLE - QTY 6
• 00850007350277 - SHAW SCALPEL: 2023-12-28 MODEL 5715 BLADE - QTY 24