FDA.report

Faichney Medical Company

Primary DI
B425FMC6469
Brand
Faichney Medical Company
Company
MEDIAID INC
Model
FMC6469
Catalog number
FMC6469
Device description
Thermometer
Published
2017-03-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B425FMC6469PrimaryHIBCC0

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
134990550
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company

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CST02021212Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-21212016-11-25
CST02021222Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-21222016-11-25
CST02021232Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-21232016-11-25
CST02021242Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-21242016-11-25
CST02022012Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-22012016-11-25
CST02022022Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-22022016-11-25
CST02022032Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-22032016-11-25
CST02022042Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-22042016-11-25
B425CST02023012Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-23012016-11-02
CST02023022Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-23022016-11-25
CST02023032Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-23032016-11-25
CST02023042Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-23042016-11-25
CST02024012Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-24012016-11-25
CST02024022Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-24022016-11-25
CST02024032Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-24032016-11-25
CST02024042Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-24042016-11-25
CST02026012Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-26012016-11-25
CST02026022Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-26022016-11-25
CST02026032Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-26032016-11-25
CST02026042Adhesive Disposable SpO2 Sensors with Micro Foam TCST020-26042016-11-25

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