Nihon Kohden Disposable

GUDID 06946725526699

APK Technology Co.,Ltd.

Pulse oximeter probe, single-use

• Primary Device ID: 06946725526699
• NIH Device Record Key: 93373634-9f42-4b78-bc53-a8f5df10d9b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nihon Kohden Disposable
• Version Model Number: A1411-SP03
• 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: true
• 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	06946725526699 [Primary]
GS1	16946725590437 [Package]; Package: [24 Units]; In Commercial Distribution

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 Disposable]

• 06946725526712: A1411-SN03
• 06946725526705: A1411-SI03
• 06946725526699: A1411-SP03
• 06946725526682: A1411-SA01C
• 06946725526675: A1411-SA03
• 06946725525159: A1411-SN02
• 06946725525142: A1411-SI02
• 06946725525135: A1411-SP02
• 06946725525128: A1411-SA02
• 06946725514245: A1411-SN01
• 06946725514238: A1411-SI01
• 06946725514221: A1411-SP01
• 06946725514214: A1411-SA01