Nihon Kohden

GUDID 06946725527047

APK Technology Co.,Ltd.

Electrocardiographic lead set, reusable

• Primary Device ID: 06946725527047
• NIH Device Record Key: e74f2d2b-5124-4053-80e5-b5feb07f09ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nihon Kohden
• Version Model Number: A0001D06-001
• Company DUNS: 529691989
• Company Name: APK Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946725527047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170536

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: 2018-08-06
• Device Publish Date: 2018-07-06

On-Brand Devices [Nihon Kohden]

• 06946725527047: A0001D06-001
• 06946725527030: A0001D06
• 06946725527023: A00001D03-001
• 06946725527016: A0001D03
• 06946725526668: A1411-SR144PU
• 06946725526651: A1411-SW144PU
• 06946725526644: A1411-SP144PU
• 06946725526637: A1411-SA144PU
• 06946725526620: A1411-SP144PV
• 06946725526613: A1411-SA144PV
• 06946725526606: A1411-SR116PU
• 06946725526590: A1411-SW116PU
• 06946725526583: A1411-SP116PU
• 06946725526576: A1411-SA116PU
• 06946725526569: A1411-SP116PV
• 06946725526552: A1411-SA116PV
• 06946725526545: A1411-SR203PU
• 06946725526538: A1411-SR136PU
• 06946725526521: A1411-SR103PU
• 06946725526514: A1411-SW203PU
• 06946725526507: A1411-SW136PU
• 06946725526491: A1411-SW103PU
• 06946725526484: A1411-SP203PU
• 06946725526477: A1411-SP136PU
• 06946725526460: A1411-SP103PU
• 06946725526453: A1411-SA203PU
• 06946725526446: A1411-SA136PU
• 06946725526439: A1411-SA103PU
• 06946725526422: A1411-SP203PV
• 06946725526415: A1411-SP136PV
• 06946725526408: A1411-SP103PV
• 06946725526392: A1411-SA203PV
• 06946725526385: A1411-SA136PV
• 06946725526378: A1411-SA103PV
• 06946725528266: NK-BR-913PA-DP
• 06946725528556: NK-BR-906PA-DP
• 06946725528549: NK-BR-916PA-DP
• 06946725538869: Compatible with GE, 3 Lead Grouped ECG lead wires,Pinch,AHA