Nihon Kohden

GUDID 06946725526521

APK Technology Co.,Ltd.

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 06946725526521
• NIH Device Record Key: cab9e6fa-417f-4d01-8479-d53579b68efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nihon Kohden
• Version Model Number: A1411-SR103PU
• 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: true
• 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	06946725526521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172981

FDA Product Code

• DQA: Oximeter

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