LDW,5 PACK,SURE-LOCL,TRU-LINK,40",BROWN 17685

GUDID 00840828138888

LDW,5 PACK,SURE-LOCL,TRU-LINK,40",BROWN

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic lead set, reusable

• Primary Device ID: 00840828138888
• NIH Device Record Key: 90bc2305-9f93-4594-b4c5-7ddac4bc342c
• Commercial Distribution Discontinuation: 2017-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LDW,5 PACK,SURE-LOCL,TRU-LINK,40",BROWN
• Version Model Number: LDW-05DC-40A4-0000
• Catalog Number: 17685
• 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	00840828138888 [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: 2016-09-24

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

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• 00840828195973 - ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680: 2026-02-19 ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680
• 00840828195980 - ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680: 2026-02-19 ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680
• 00840828195997 - ZEPHYR,800,10,SIP,JERON 680: 2026-02-19 ZEPHYR,800,10,SIP,JERON 680
• 00840828195928 - GEN4 INTERACTIVE: 2026-02-13
• 00840828195935 - GEN4 INTERACTIVE: 2026-02-13
• 00840828195942 - GEN4 INTERACTIVE: 2026-02-13 GEN4 INTERACTIVE
• 00840828195959 - GEN4 INTERACTIVE: 2026-02-13 GEN4 INTERACTIVE