Amazon Basic Care

GUDID 00195515047944

Amazon Basic Care Pulse Oximeter

AMAZON.COM SERVICES LLC

Pulse oximeter probe, reusable

• Primary Device ID: 00195515047944
• NIH Device Record Key: 859b10b4-e236-4801-8105-81277a6e36d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amazon Basic Care
• Version Model Number: B09S3W7SW7
• Company DUNS: 128990418
• Company Name: AMAZON.COM SERVICES LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195515047944 [Primary]
GS1	10195515047941 [Package]; Package: SHIPPER [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

FDA Product Code

• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2023-12-29
• Device Publish Date: 2023-12-21

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