Breathe Pure

GUDID 10810021178377

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin
Primary Device ID10810021178377
NIH Device Record Keydc3e67d9-5320-424b-a568-6488fbf58c37
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreathe Pure
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

Customer Support Contacts

Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com
Phone+86 15166110228
Email15166110228@163.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810021178363 [Primary]
GS110810021178377 [Package]
Contains: 00810021178363
Package: [1 Units]
In Commercial Distribution
GS120810021178428 [Package]
Package: [3 Units]
In Commercial Distribution
GS130810021178050 [Package]
Contains: 20810021178428
Package: [2 Units]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-24
Device Publish Date2020-12-16

Devices Manufactured by Dongguan SIMZO Electronic Technology Co., Ltd.

00810021174013 - NA2024-01-11
10810021174034 - NA2024-01-11
00810021171166 - SIMZO2021-07-28
00810021171173 - SIMZO2021-07-28
00810021171180 - SIMZO2021-07-28
00810021171197 - simzo2021-07-28
00810021171203 - SIMZO2021-07-28
00810021171210 - SIMZO2021-07-28

Trademark Results [Breathe Pure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BREATHE PURE
BREATHE PURE
90059540 not registered Live/Pending
Tristar Products, Inc.
2020-07-17
BREATHE PURE
BREATHE PURE
88680575 not registered Live/Pending
McDowell, Michael
2019-11-05
BREATHE PURE
BREATHE PURE
78341069 3056341 Dead/Cancelled
BREATHEPURE HEALTHCARE, L.L.C.
2003-12-15

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