Tempa Check 4-in-1 Infrared thermometer

DI: 00891237001270 · Model: FDIR-V1 · HOME AIDE DIAGNOSTICS, INC.

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

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Basic Information

Brand Name: Tempa Check 4-in-1 Infrared thermometer
Primary DI: 00891237001270
Version / Model: FDIR-V1
Catalog Number: 1270
Company Name: HOME AIDE DIAGNOSTICS, INC.
Labeler DUNS: 783518983
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-06-21
Public Version: 4
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: 0bcfe8ba-3260-4988-9a42-e018b80d4bb4

Device Description

Medical thermometer for measuring ear/ forehead/ object temperature/ ambient temperature of human body via infrared rays emitted from the eardrum and skin surface. Measuring range: 32.0-42.9°C (89.6-109.2°F)

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
14035	Intermittent electronic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00891237001270	GS1
Package	10891237001277	GS1	Case	50	In Commercial Distribution

Customer Contacts

Phone: 1-800-915-0116
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K052849	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 0 – 95 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: -13 – 131 Degrees Fahrenheit
Type: Storage Environment Atmospheric Pressure
Temperature Range: -25 – 55 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 20 – 95 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 59 – 104 Degrees Fahrenheit
Type: Handling Environment Temperature
Temperature Range: 15 – 40 Degrees Celsius