FDA.reportPublic FDA data

Sharn Inc

Primary DI
00817518021393
Brand
Sharn Inc
Company
Sharn Anesthesia
Model
42827
Catalog number
42827
Device description
Moving Line Temperature Indicator
Published
2018-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00817518021393PrimaryGS10
00817518021829Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817518021393008175180213938175180213930817518021393
00817518021829008175180218298175180218290817518021829

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
107996118
Device count
12
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518020129Sharn IncBAT1-100BAT1-1002018-09-26
00817518022109Sharn IncS2020S20202018-11-16
00817518022123Sharn IncS2020-ES2020-E2018-11-16
00817518022147Sharn IncS2020-MS2020-M2018-11-16
00817518022161Sharn IncS2020-PS2020-P2018-11-16
00817518022550Sharn Anesthesia105604-EU2022-10-27
00817518022567Sharn Anesthesia105605-EU2022-10-27
00817518022574Sharn Anesthesia105606-EU2022-10-27
00817518022581Sharn Anesthesia105607-EU2022-10-27
00817518022598Sharn Anesthesia105608-EU2022-10-27
00817518022468SharnSelect45-18520SS2022-06-20
00817518022475SharnSelect45-18530SS2022-06-20
00817518022482SharnSelect45-18540SS2022-06-20
00817518022499SharnSelect45-18550SS2022-06-20
00817518022505SharnSelect45-18560SS2022-06-20
00817518022512SharnSelect45-18515SS2022-06-20
00817518022529SharnSelect45-18525SS2022-06-20
00817518022536SharnSelect45-185150SS2022-06-20
00817518022543SharnSelect45-185200SS2022-06-20
00817518021546Sharn IncPI-803S-6PI-803S-62018-10-10

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