BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Hetaida

DI: 06970289035557 · Model: HTD8208C · Hetaida Technology Co., Ltd

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Hetaida
Primary DI: 06970289035557
Version / Model: HTD8208C
Company Name: Hetaida Technology Co., Ltd
Labeler DUNS: 544474402
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-12-13
Public Version: 1
Public Version Date: 2022-12-21
Public Version Status: New
Public Device Record Key: dc353220-cee6-4666-958a-610aea49322c

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	16970289035554	GS1		100	In Commercial Distribution
Primary	06970289035557	GS1

Premarket Submissions

Submission Number	Supplement Number
K180387	000

Device Sizes

Type	Value	Unit	Text
Height	45	Millimeter
Width	36	Millimeter
Length	160	Millimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 55 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 0 – 93 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 15 – 35 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 0 – 85 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal