Handheld Pulse Oximeter

GUDID 06941900604001

Shenzhen Creative Industry Co., Ltd.

Pulse oximeter
Primary Device ID06941900604001
NIH Device Record Key4ada2a11-788e-4d55-937b-11b856f2954b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandheld Pulse Oximeter
Version Model NumberSP-20
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
GS106941900604001 [Primary]

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 Date2021-11-10
Device Publish Date2019-08-27

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
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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