Patient Lead Wire Adapter Set

GUDID 00817266020778

Lead wire adapter set - NIKOMED 10 pack

MERIT CABLES INCORPORATED

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• Primary Device ID: 00817266020778
• NIH Device Record Key: ac7d2249-a82e-4660-95ff-b9b29de65a6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Lead Wire Adapter Set
• Version Model Number: 41431
• Company DUNS: 180587883
• Company Name: MERIT CABLES INCORPORATED
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817266020778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942321

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: 2018-03-29
• Device Publish Date: 2017-05-09

Devices Manufactured by MERIT CABLES INCORPORATED

• 90817266020863 - Patient Leadwire: 2018-12-21 3 Lead Wire Assembly: socket connector to snaps
• 90817266020856 - Patient Lead Wire Set of 4: 2018-07-16 4 Lead Wire Set: socket to snap (Brown, Red, White, Orange), various lengths
• 90817266020788 - Patient Leadwire: 2018-06-14 3 Lead Set .080 Socket to Pinch, Various Lengths and Colors
• 90817266020832 - Patient Cables: 2018-04-23 5 Lead Patient Trunk Cable
• 90817266020009 - Patient Cable: 2018-03-29 4 Lead Patient Cable Telemetry, Various Lengths
• 90817266020016 - Patient Cable: 2018-03-29 3 Lead Patient Cable Telemetry
• 90817266020023 - Patient Cable: 2018-03-29 Patient Cable - Holter 2 Leadwire snap.
• 90817266020030 - Patient Cable: 2018-03-29 Patient Cable - Din Style, 3 Lead