ADTEMP 425-40

GUDID 00634782562762

ADTEMP Tympanic Probe Covers,40/pkg

AMERICAN DIAGNOSTIC CORP

Electronic thermometer probe cover

• Primary Device ID: 00634782562762
• NIH Device Record Key: a218bd85-a984-4059-9a10-0d7fe4195161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADTEMP
• Version Model Number: 425-40
• Catalog Number: 425-40
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• Device Count: 40
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782062958 [Primary]
GS1	00634782094492 [Unit of Use]
GS1	00634782562762 [Package]; Contains: 00634782862763; Package: MASTER [4 Units]; In Commercial Distribution
GS1	00634782862763 [Package]; Contains: 00634782062958; Package: INNER PACK [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102508

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: 2018-08-13
• Device Publish Date: 2018-07-13

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