FDA.report

NC° thermometer

Primary DI
16970094056003
Brand
NC° thermometer
Company
Xiamen Intretech Inc.
Model
Gen3
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K223522000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223522000NC° Thermometer (Gen 3), Model Number: NCTG3Xiamen Intretech, Inc.2023-06-20FLL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16970094056003PackageGS11In Commercial Distribution
06970094056006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697009405600316970094056003
06970094056006069700940560066970094056006

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
421274505
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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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