SURE LOCK, ASSEMBLY, A34, GREEN LEVER 27758

GUDID 00840828187428

SURE LOCK, ASSEMBLY, A34, GREEN LEVER

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic electrode, reusable

• Primary Device ID: 00840828187428
• NIH Device Record Key: 5eb12eae-2f0e-4db0-ac10-400eecd9897d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURE LOCK, ASSEMBLY, A34, GREEN LEVER
• Version Model Number: SLC-4200-005
• Catalog Number: 27758
• Company DUNS: 796452311
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828187367 [Primary]
GS1	00840828187428 [Package]; Contains: 00840828187367; Package: BAG [10 Units]; In Commercial Distribution
GS1	00840828187435 [Package]; Contains: 00840828187367; Package: BAG [14 Units]; In Commercial Distribution
GS1	00840828188951 [Package]; Contains: 00840828187367; Package: Pack [14 Units]; In Commercial Distribution
GS1	00840828188968 [Package]; Contains: 00840828187367; Package: Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080605

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: 2
• Public Version Date: 2023-04-26
• Device Publish Date: 2023-01-09

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

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• 00840828194440 - GEN4 INTERACTIVE: 2025-08-19
• 00840828194457 - RESPONDER 5, INTERACTIVE: 2025-08-19
• 00840828194464 - GEN4 INTERACTIVE: 2025-08-19
• 00840828194471 - RESPONDER 5, INTERACTIVE: 2025-08-19
• 00840828194488 - GEN4 INTERACTIVE: 2025-08-19
• 00840828194495 - GEN4 INTERACTIVE: 2025-08-19