Adtemp™

Basic Information

• Brand Name: Adtemp™
• Primary DI: 00634782098407
• Version / Model: 433
• Catalog Number: 433
• Company Name: AMERICAN DIAGNOSTIC CORP
• Labeler DUNS: 108999095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-31
• Public Version: 6
• Public Version Date: 2024-01-18
• Public Version Status: Update
• Public Device Record Key: a4c0944f-e696-4235-8291-9eafdb345441

Device Description

ADTEMP Non-Contact IR Thermometer, Trigger type, 1 second

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00634782899783	GS1	Inner Pack	6	In Commercial Distribution
Primary	00634782098407	GS1
Package	00634782599782	GS1	Master Case	8	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171888	000
K203332	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity