FDA.reportPublic FDA data

JJ CARE

Primary DI
15060988910021
Brand
JJ CARE
Company
Jack Jack LLC
Model
KFT-03
Device description
Oral Thermometer- Features a short, flexible waterproof probe that is more comfortable than other models. The display takes only 10 seconds to register the temperature, featuring a liquid crystal display and are easily switchable from Celsius to Fahrenheit. With fever Alarm - High body temperature indication function.
Published
2023-03-15
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060988910024Direct MarkingGS10
25060988910028PackageGS1500In Commercial Distribution
15060988910021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060988910024050609889100245060988910024
2506098891002825060988910028
1506098891002115060988910021

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method
Chlorine Dioxide

Contacts#

Phone, Email table
PhoneEmail
18334201183support@jackjackllc.com

Regulatory Flags#

DUNS number
052514128
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060988910062JJ CAREJJ033112P-602023-07-15
05060988910079JJ CAREJJ033112P-1002023-07-15
05060988910086JJ CAREJJ102912-1202023-07-15
05060988910093JJ CAREJJ102912-302023-07-15
05060988910109JJ CAREJJ103012-1002023-07-15
05060988910116JJ CAREJJ103012-302023-07-15
05060988910123JJ CAREJJ103108-1002023-07-15
05060988910130JJ CAREJJ103108-1002023-07-15
05060988910147JJ CAREJJ103108-302023-07-15
05060988910154JJ CAREJJ053108-1002023-07-15
05060988910161JJ CAREJJ033108-1002023-07-15
15060988910045JJ CARE300232023-07-15
15060988910007JJ CAREHH-X-T, IC2023-03-15
15060988910014JJ CAREKFT-092023-03-15
15060988910038JJ CAREHH-X-T2023-03-15

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Primary DI, Brand, Company table
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