Adview 9000TP

GUDID 00634782065201

Adview Probe Covers, 500/tray,20/box, 25 boxes/tray

AMERICAN DIAGNOSTIC CORP

Electronic thermometer probe cover

• Primary Device ID: 00634782065201
• NIH Device Record Key: aa5aa366-c5d5-4cf7-a960-27ba04d111c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adview
• Version Model Number: 9000TP
• Catalog Number: 9000TP
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• Device Count: 500
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782065201 [Package]; Contains: 00634782564650; Package: Master [10 Units]; In Commercial Distribution
GS1	00634782094539 [Unit of Use]
GS1	00634782564650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070750

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2018-08-31
• Device Publish Date: 2018-07-31

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