TRUNK CBL,5LD,SPACELABS,TWIN PIN,10',AHA 22098

GUDID 00840828159883

TRUNK CBL,5LD,SPACELABS,TWIN PIN,10',AHA

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic electrode connector

• Primary Device ID: 00840828159883
• NIH Device Record Key: 4f3a2df8-728e-4ea0-8d29-d5324b0073e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUNK CBL,5LD,SPACELABS,TWIN PIN,10',AHA
• Version Model Number: TCB-05MB-10AS-0030
• Catalog Number: 22098
• Company DUNS: 796452311
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1-800-235-7500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828159883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081762

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-22