Prexiso

GUDID 28100211780176

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin
Primary Device ID28100211780176
NIH Device Record Keyd117562d-9b3b-4779-abfb-371d880ed584
Commercial Distribution Discontinuation2020-04-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePrexiso
Version Model NumberHW-F7
Company DUNS544332470
Company NameDongguan SIMZO Electronic Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108100211780172 [Primary]
GS118100211780179 [Package]
Contains: 08100211780172
Package: [1 Units]
Discontinued: 2020-04-05
Not in Commercial Distribution
GS128100211780176 [Package]
Contains: 18100211780179
Package: [60 Units]
Discontinued: 2020-04-05
Not in Commercial Distribution
GS128100211780183 [Package]
Contains: 08100211780172
Package: [6 Units]
Discontinued: 2020-04-05
Not in Commercial Distribution
GS138100211780173 [Package]
Contains: 28100211780183
Package: [10 Units]
Discontinued: 2020-04-05
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-17
Device Publish Date2020-04-05

On-Brand Devices [Prexiso]

28100211780176HW-F7
10810021178049HW-F7

Trademark Results [Prexiso]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREXISO
PREXISO
88915512 not registered Live/Pending
Prexiso AG
2020-05-14
PREXISO
PREXISO
79106339 4220009 Live/Registered
Prexiso AG
2011-06-16
PREXISO
PREXISO
79047543 3537322 Live/Registered
Prexiso AG
2007-07-30

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