ONE PIECE MOLDED,5LD,GE,PINCH,10',AHA 22614

GUDID 00840828161909

ONE PIECE MOLDED,5LD,GE,PINCH,10',AHA

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic lead set, reusable

• Primary Device ID: 00840828161909
• NIH Device Record Key: c2ea02e8-66fe-4601-a4ad-ecda370c0cf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE PIECE MOLDED,5LD,GE,PINCH,10',AHA
• Version Model Number: MCB-05NB-10AS-0002
• Catalog Number: 22614
• 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	00840828161909 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-30
• Device Publish Date: 2018-07-30