LW NKN,6LEAD,MLD,PNCH, 29"AHA,INTERMED 18831

GUDID 00840828140478

LW NKN,6LEAD,MLD,PNCH, 29"AHA,INTERMED

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic lead set, reusable

• Primary Device ID: 00840828140478
• NIH Device Record Key: d0d9007a-9bac-4446-9077-222ab31a2ec3
• Commercial Distribution Discontinuation: 2017-12-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LW NKN,6LEAD,MLD,PNCH, 29"AHA,INTERMED
• Version Model Number: LDW-06BF-29AN-3000
• Catalog Number: 18831
• 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	00840828140478 [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.

• 00840828193221 - GEN4 DIGITAL: 2024-11-18 GEN4 DIGITAL
• 00840828193238 - GEN4 INTERACTIVE: 2024-11-18
• 00840828193245 - CLICK,8 PIN DIN,8 FT,WHITE,TT WIRING: 2024-11-18
• 00840828193252 - CLICK,8 PIN DIN,20 FT,WHITE,TT WIRING: 2024-11-18
• 00840828193269 - RESPONDER 5, INTERACTIVE: 2024-11-18
• 00840828193276 - CLICK,1/4" PLUG (P102),6 IN,WHITE: 2024-11-18
• 00840828193283 - CLICK,1/4" PLUG (P102),20 FT,WHITE: 2024-11-18
• 00840828193290 - CLICK,8 PIN DIN,6 IN,WHITE,TT WIRING: 2024-11-18