FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756142040
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
81-010003
Device description
SensoStrip 2 Temperature Indicator
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
50749756142040PackageGS1100In Commercial Distribution
00749756142045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975614204050749756142040
00749756142045007497561420457497561420450749756142045

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(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

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