SURE LOCK,A34,10 PK,GREEN LEVER,VYAIRE 26866

GUDID 00840828183369

SURE LOCK,A34,10 PK,GREEN LEVER,VYAIRE

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic electrode, reusable

• Primary Device ID: 00840828183369
• NIH Device Record Key: e674b214-f5cd-4d5c-94d1-592520e63880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURE LOCK,A34,10 PK,GREEN LEVER,VYAIRE
• Version Model Number: CL-10401-05-10
• Catalog Number: 26866
• 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
• 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	00840828183369 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-05
• Device Publish Date: 2021-04-27

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

• 00840828187381 - SURE LOCK, ASSEMBLY, A34, RED LEVER: 2025-04-02 SURE LOCK, ASSEMBLY, A34, RED LEVER
• 00840828187404 - SURE LOCK, ASSEMBLY, A34, ORANGE LEVER: 2025-04-02 SURE LOCK, ASSEMBLY, A34, ORANGE LEVER
• 00840828194204 - GEN4 AUSTCO TACERA ENTERTAINMENT: 2025-03-14
• 00840828194211 - GEN4 PLUS, DIRECT ACCESS: 2025-03-14
• 00840828194280 - GEN4 INTERACTIVE: 2025-03-14
• 00840828194297 - GEN4 INTERACTIVE: 2025-03-14
• 00840828194303 - GEN4 INTERACTIVE: 2025-03-14
• 00840828194228 - REGO 1.1,PID,NO AUX,14': 2025-03-07