Oximeter Plus

GUDID 00860298000010

Fingertip Pulse Oximeter

OXIMETER PLUS, INC.

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• Primary Device ID: 00860298000010
• NIH Device Record Key: 10709ee1-212b-415b-ab48-14dde69ac136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oximeter Plus
• Version Model Number: C21
• Company DUNS: 829005607
• Company Name: OXIMETER PLUS, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx
• Phone: 516-626-6226
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860298000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161560

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: 2016-11-04

On-Brand Devices [Oximeter Plus]

• 00860298000119: Fingertip Pulse Oximeter
• 00860298000102: Fingertip Pulse Oximeter
• 00860298000096: Fingertip Pulse Oximeter
• 00860298000089: Fingertip Pulse Oximeter
• 00860298000010: Fingertip Pulse Oximeter