FDA.report

Kerma

Primary DI
00634782595302
Brand
Kerma
Company
AMERICAN DIAGNOSTIC CORP
Model
413RKKM
Catalog number
413RKKM
Device description
SPU Digital Thermometer Kit,Rectal, KM PL
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782595302PackageGS16In Commercial Distribution
00634782895303PackageGS124In Commercial Distribution
00634782093884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782595302006347825953026347825953020634782595302
00634782895303006347828953036347828953030634782895303
00634782093884006347820938846347820938840634782093884

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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