Pulse Oximeter

GUDID 00616784708836

DYNAREX CORPORATION

Pulse oximeter, battery-powered

• Primary Device ID: 00616784708836
• NIH Device Record Key: d213e047-9e97-4d29-b3ab-b0a859e79a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Oximeter
• Version Model Number: 7088
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00616784708812 [Primary]
GS1	00616784708836 [Package]; Contains: 00616784708812; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070371

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Pulse Oximeter]

• 00616784709031: 7090
• 00616784708935: 7089
• 00616784708836: 7088
• 00840117310223: Pulse Oximeter, Pediatric
• 00840117310162: Pulse Oximeter