FeverScan Ultra

GUDID 00815236020919

Reusable Forehead Thermometer

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use
Primary Device ID00815236020919
NIH Device Record Key44981e6f-90d6-413e-bfc0-9f001f52547e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFeverScan Ultra
Version Model Number1026B1
Company DUNS059247507
Company NameLCR HALLCREST, LLC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100815236020919 [Primary]
GS110815236020916 [Package]
Package: 1CTN [1 Units]
In Commercial Distribution
GS120815236020913 [Package]
Contains: 10815236020916
Package: 1BX [1 Units]
In Commercial Distribution
GS130815236020910 [Package]
Contains: 20815236020913
Package: 12BG [12 Units]
In Commercial Distribution
GS140815236020917 [Package]
Contains: 10815236020916
Package: 5BG [5 Units]
In Commercial Distribution
GS150815236020914 [Package]
Package: 2BX [2 Units]
In Commercial Distribution

FDA Product Code

KPDStrip, Temperature, Forehead, Liquid Crystal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-05-09

On-Brand Devices [FeverScan Ultra]

00815236020919Reusable Forehead Thermometer
00815236020391FeverScan Ultra Reusable Forehead Thermometer
00815236021039Reusable Liquid Crystal Forehead Thermometer - 12 Event, Celsius only with Blank Tabs
00815236021022Reusable Liquid Crystal Forehead Thermometer - 12 Event, Dual Scale, with Blank Tabs

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.