Alcedo

GUDID 10856471007201

Fingertip Pulse Oximeter

NATURE MAJOR INC

Pulse oximeter, battery-powered

• Primary Device ID: 10856471007201
• NIH Device Record Key: 93811b5a-b92c-4052-9c23-88e4bd25fa8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcedo
• Version Model Number: AE174
• Company DUNS: 114908257
• Company Name: NATURE MAJOR INC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856471007204 [Primary]
GS1	10856471007201 [Package]; Contains: 00856471007204; Package: Master carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140582

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: 2020-04-14
• Device Publish Date: 2020-04-06

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