FDA.reportPublic FDA data

Adtemp™

Primary DI
00634782083038
Brand
Adtemp™
Company
AMERICAN DIAGNOSTIC CORP
Model
417
Catalog number
417
Device description
ADTEMP Ultra Dig Thermometer,2 sec, Flex tip, Lrg Disp
Published
2016-09-21
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
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983887000UP-GRADE AND UP-GRADE PROMedisim, Ltd.1999-02-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782584412PackageGS14In Commercial Distribution
00634782884413PackageGS140In Commercial Distribution
00634782083038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782584412006347825844126347825844120634782584412
00634782884413006347828844136347828844130634782884413
00634782083038006347820830386347820830380634782083038

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 Temperature-4 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782102524Diagnostix™805MTA805MTA2026-10-16
00634782102449Multikuf™731-MCC1UB731-MCC1UB2026-10-06
00634782101725Diagnostix™805M805M2026-03-30
00634782102357ADView® 2.69006BPC9006BPC2026-10-06
00634782102456Diagnostix™54310LUB54310LUB2026-10-06
00634782102517ADC8974MAD8974MAD2026-10-06
00634782096427Multikuf™731-MCC1731-MCC12020-08-29
00634782102159Diagnostix™805NWWA805NWWA2026-08-26
00634782102166Diagnostix™805NMWA805NMWA2026-08-26
00634782102173Diagnostix™805NDWA805NDWA2026-08-26
00634782102197Adcuff™885TAWA885TAWA2026-08-26
00634782102203Adcuff™885NWA885NWA2026-08-26
00634782102210Adcuff™886NWA886NWA2026-08-26
00634782101459Prosphyg™760-11ABCAA760-11ABCAA2026-08-25
00634782101633Diagnostix™2101CN2101CN2026-08-25
00634782101848Adscope®603BKAC603BKAC2026-08-25
00634782102098Proscope™664BKKM664BKKM2026-08-25
00634782102104Proscope™664YKM664YKM2026-08-25
00634782102111Proscope™665YKM665YKM2026-08-25
00634782102128Adsoft™660-08BK660-08BK2026-08-25

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Primary DI, Brand, Company table
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