Exergen Temporal Scanner

Basic Information

• Brand Name: Exergen Temporal Scanner
• Primary DI: 00834098002109
• Version / Model: TAT2000C
• Catalog Number: 140010, 140022, 144010, 140019, 144035, 144056, 144061, 144065, 144070, 140061
• Company Name: EXERGEN CORPORATION
• Labeler DUNS: 061266060
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-03-03
• Public Version Status: Update
• Public Device Record Key: 006016e1-d480-4d40-90b7-0453656dcc6b

Device Description

TAT2000C Temporal Scanner

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	10834098002106	GS1	box	3	In Commercial Distribution
Primary	00834098002109	GS1
Package	30834098002100	GS1	Case	12	In Commercial Distribution
Package	50834098002104	GS1	Pallet	27	Not in Commercial Distribution	2017-03-31
Package	40834098002107	GS1	Box	20	In Commercial Distribution
Package	60834098002101	GS1	Case	21	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011291	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit