Spiras 18866

GUDID 10815236020374

7 Event Horizontal Temperature Trend Indicator

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use
Primary Device ID10815236020374
NIH Device Record Key173303ee-a5cc-41be-9c53-eeb32738661f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiras
Version Model Number18866
Catalog Number18866
Company DUNS059247507
Company NameLCR HALLCREST, LLC.
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100815236020377 [Unit of Use]
GS110815236020374 [Primary]

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 Number3
Public Version Date2020-02-24
Device Publish Date2016-09-23

On-Brand Devices [Spiras]

108152360203747 Event Horizontal Temperature Trend Indicator
108152360203676 Event Horizontal Temperature Trend Indicator
1081523602035011 Event Horizontal Temperature Trend Indicator

Trademark Results [Spiras]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIRAS
SPIRAS
76066563 not registered Dead/Abandoned
Spiras Corporation
2000-06-09

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