Indwelling Slit Catheter

GUDID 00850007350000

Indwell Slit Catheter Set (12/pkg). Each set includes slit catheter, breakaway needle and extension tubing.

C2DX, INC.

Compartmental-pressure monitoring system, single-use

• Primary Device ID: 00850007350000
• NIH Device Record Key: 3e8bd904-d1f1-4a40-998a-02f6e4e65bc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indwelling Slit Catheter
• Version Model Number: 0295-006-000
• 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	00850007350000 [Unit of Use]
GS1	10850007350007 [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

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• 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