Adimals® 426F

GUDID 00634782563080

ADTEMP Adimal Dig. Thermometer,Dual Scale, Flex tip, Frog

AMERICAN DIAGNOSTIC CORP

Intermittent electronic patient thermometer

• Primary Device ID: 00634782563080
• NIH Device Record Key: 70dd34e8-c0bd-482d-bc38-7f98c3aa03e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adimals®
• Version Model Number: 426F
• Catalog Number: 426F
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• 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

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 -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782063276 [Primary]
GS1	00634782563080 [Package]; Contains: 00634782863081; Package: Master Case [12 Units]; In Commercial Distribution
GS1	00634782863081 [Package]; Contains: 00634782063276; Package: Inner Pack [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100563

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2016-09-21

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• 00634782563073: ADTEMP Adimal Dig. Thermometer,Dual Scale, Flex tip, Bear
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• 00634782859749: Chestpiece for 617 w/Panda,Adult, White
• 00634782859732: Chestpiece for 617 w/Panda,Adult, Seafoam
• 00634782859725: Chestpiece for 617 w/Panda,Adult, Pink
• 00634782559663: Chestpiece Snap-ons Kit-617,Adult, Set of 6
• 00634782559656: ADSCOPE ADimal Scope,Adult-30", White