FDA.reportPublic FDA data

LEADER

Primary DI
00096295134155
Brand
LEADER
Company
Cardinal Health 110, Inc.
Model
5427802
Catalog number
5427802
Device description
9 ea 60-second Digital Thermometer Display Box
Published
2019-05-01
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
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDVClinical Electronic ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30096295134156PackageGS11In Commercial Distribution
50096295134150PackageGS124In Commercial Distribution
00096295134155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3009629513415630096295134156
5009629513415050096295134150
00096295134155000962951341550962951341550096295134155

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity095 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)200-6313xxx@xxx.xxx

Regulatory Flags#

DUNS number
063997360
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00096295133219LEADER540277154027712020-01-02
00096295141504LEADER574184857418482022-01-14
00096295141511LEADER574185557418552022-01-14
00096295141528LEADER574186357418632022-01-14
00096295141535LEADER574187157418712022-01-14
00096295141542LEADER574188957418892022-01-14
00096295137309LEADER551288455128842019-06-20
00096295120851LEADER449066044906602019-10-21
00096295137347LEADER551320555132052019-10-21
00096295141146LEADER574643357464332022-01-06
00096295128789LEADER523850652385062017-02-23
00096295128796LEADER523854852385482017-02-23
00096295129212LEADER527880952788092017-02-23
00096295133202LEADER540276354027632019-07-26
00096295145137LEADER596875559687552025-09-09
50096295145132LEADER596875559687552025-09-09
00096295137262LEADER551284355128432019-06-20
00096295137293LEADER551287655128762019-08-29
00096295137279LEADER551285055128502019-06-20
00096295120905LEADER449081944908192017-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970392211701NAJOYTECH HEALTHCARE CO.,LTDSDV2026-05-20
06933257929432YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257930711YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931213YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931244YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931251YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931268YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
10840330706558ProCureTwin Med, LLCSDV2026-05-05
10840330706565ProCureTwin Med, LLCSDV2026-05-05
06953775662451@AL21Alicn Medical Shenzhen, Inc.SDV2026-04-16
00860015673107Inito InTemp Basal ThermometerInito Health, Inc.SDV2026-04-08
06953775662345BBLOVEAlicn Medical Shenzhen, Inc.SDV2026-03-26
06953775662369AILIFEEAlicn Medical Shenzhen, Inc.SDV2026-03-26
06953775662383AILIFEEAlicn Medical Shenzhen, Inc.SDV2026-03-26
04719003406516MicrolifeMICROLIFE USA, INC.SDV2026-01-31
04719883871350Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871374Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871381Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871435Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883870070ForeHealthFORTECHGRP CO., LTD.SDV2026-01-26
00194346614042EquateWAL-MART STORES, INC.SDV2026-01-21
06947656117932BERRCOMGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118014BerrcomGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118021DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118038DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118045DedeksGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
06947656118052BERRCOMGuangzhou Berrcom Medical Device Co., LtdSDV2026-01-21
00850044118694iHealthiHealth Labs Inc.SDV2025-12-19
00850044118700iHealthiHealth Labs Inc.SDV2025-12-19
00850044118724iHealthiHealth Labs Inc.SDV2025-12-19