RLW,5 LEAD,SNAP,MX40 W/O SPO2,34",AHA 24435

GUDID 00840828165211

RLW,5 LEAD,SNAP,MX40 W/O SPO2,34",AHA

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic lead set, reusable

• Primary Device ID: 00840828165211
• NIH Device Record Key: 40adb111-09d0-483e-b866-2eeaef5acac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RLW,5 LEAD,SNAP,MX40 W/O SPO2,34",AHA
• Version Model Number: RLW-05AY-34AS-0000
• Catalog Number: 24435
• 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
• Phone: 1-800-235-7500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828165211 [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: 2019-03-19
• Device Publish Date: 2019-03-11

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

• 00840828195331 - RESPONDER 5, INTERACTIVE: 2025-11-19
• 00840828195355 - JUMPER,8FT,P102 TO 7 PIN DIN: 2025-11-19 JUMPER,120",P103 TO RJ12
• 00840828195362 - RESPONDER 5, INTERACTIVE: 2025-11-19
• 00840828195379 - GEN4 DIRECT ACCESS: 2025-11-19
• 00840828195386 - GEN4 INTERACTIVE: 2025-11-19
• 00840828195393 - GEN4 INTERACTIVE: 2025-11-19
• 00840828195072 - 3701(90) P37(90),1TO1,36": 2025-09-17
• 00840828194433 - BED COVER 8X36X86 P500 VC STEP DECK - PC: 2025-08-19 BED COVER 8X36X86 P500 VC STEP DECK - PC