All-in-One Health Monitor

GUDID 06941900603523

Shenzhen Creative Industry Co., Ltd.

Multiple physiological parameter spot-check analysis system, clinical
Primary Device ID06941900603523
NIH Device Record Key8768ba04-6b83-4e12-aae6-46042f949895
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll-in-One Health Monitor
Version Model NumberPC-303
Company DUNS547908801
Company NameShenzhen Creative Industry 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106941900603523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRecorder, Magnetic Tape, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-30
Device Publish Date2018-09-29

Devices Manufactured by Shenzhen Creative Industry Co., Ltd.

06941900604407 - Pulse Oximeter2023-08-16
06941900604414 - Pulse Oximeter2023-08-11
06941900603011 - Pulse Oximeter2021-11-10
06941900603240 - Pulse Oximeter2021-11-10
06941900604001 - Handheld Pulse Oximeter2021-11-10
06941900604285 - Patient Monitor2021-03-01
06941900600089 - Pulse Oximeter2019-10-22
06941900603066 - Easy ECG Monitor2018-11-16

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