FDA.reportPublic FDA data

Crystaline II

Primary DI
10815236020138
Brand
Crystaline II
Company
LCR HALLCREST, LLC.
Model
5101-II
Catalog number
5101-II
Device description
Crystaline II Liquid Crystal Temperature Trend Indicators - Envelope of 1
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPDStrip, Temperature, Forehead, Liquid Crystal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPDStrip, Temperature, Forehead, Liquid CrystalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815236020135PackageGS125In Commercial Distribution
30815236020132PackageGS1100In Commercial Distribution
40815236020139PackageGS1100In Commercial Distribution
50815236020136PackageGS11000In Commercial Distribution
10815236020138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081523602013520815236020135
3081523602013230815236020132
4081523602013940815236020139
5081523602013650815236020136
1081523602013810815236020138

GMDN Terms#

Term, Definition table
TermDefinition
Liquid-crystal patient thermometer, single-useA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature60 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-325-3671mailbox@sharn.com

Regulatory Flags#

DUNS number
059247507
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815236020671FeverScanBB150BB1502016-09-24
10815236020695FeverScanBB150BB1502016-09-24
00815236020926HemoTemp II Activator90002022-06-16
10815236021050HemoTemp20002022-06-20
10815236021074TempTrend II11002022-06-20
10815236021104StaFreez50002022-06-20
10815236021135LabTemp 4061002022-06-20
20815236021057HemoTemp20002022-06-20
20815236021071TempTrend II11002022-06-20
20815236021101StaFreez50002022-06-20
20815236021132LabTemp 4061002022-06-20
10815236021128LabTemp 2060002022-06-16
10815236020923HemoTemp II Activator90002022-06-16
20815236021125LabTemp 2060002022-06-16
10815236020176Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
10815236020183Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01
10815236020190Crystaline® Moving Line5101SD-MLC5101SD-MLC2022-03-01
10815236020206Crystaline® Moving Line5101SB-MLC5101SB-MLC2022-03-01
20815236020173Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
20815236020180Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053907173Xpect / Temp-N-TossCintas Corporation No. 2KPD2025-03-20
10850053907170Xpect / Temp-N-TossCintas Corporation No. 2KPD2025-03-20
00850018561204LC Accu-Bar Temperature Trend IndicatorINTERNATIONAL BIOMEDICAL, LTD.KPD2023-06-20
00057565168102FeverScan Fever Indicators by Physio LogicA.M.G. Médicale IncKPD2023-06-13
00057565976042FeverScan Fever Indicators by Physio LogicA.M.G. Médicale IncKPD2023-06-13
10815236021074TempTrend IILCR HALLCREST, LLC.KPD2022-06-20
20815236021071TempTrend IILCR HALLCREST, LLC.KPD2022-06-20
10815236020176Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
10815236020183Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
10815236020190Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
10815236020206Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
20815236020173Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
20815236020180Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
20815236020197Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
00815236020209Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
00050428313176CVS FOREHEAD THERMOMETERWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKPD2022-02-25
00815236021091FeverScanLCR HALLCREST, LLC.KPD2022-01-04
10815236021098FeverScanLCR HALLCREST, LLC.KPD2022-01-04
00815236020933Peppa PigLCR HALLCREST, LLC.KPD2021-12-09
10190752144484Vital Signs™AIRLIFEKPD2021-05-07
50190752144482Vital Signs™VYAIRE MEDICAL, INC.KPD2021-05-07
10888277681958MedlineMEDLINE INDUSTRIES, INC.KPD2020-12-10
20888277681955MedlineMEDLINE INDUSTRIES, INC.KPD2020-12-10
30815236020101Crystaline IILCR HALLCREST, LLC.KPD2020-10-26
30815236020323TempAlert IILCR HALLCREST, LLC.KPD2020-10-26
00815236021046FeverScan Mini DisposableLCR HALLCREST, LLC.KPD2020-10-26
10815236021043FeverScan Mini DisposableLCR HALLCREST, LLC.KPD2020-10-26
00815236020100Crystaline IILCR HALLCREST, LLC.KPD2020-10-26
00815236020322TempAlert IILCR HALLCREST, LLC.KPD2020-10-26
00029431000021ATI, Inc.AMERICAN THERMAL INSTRUMENTS, INC.KPD2020-09-30