Fingertip Pulse Oximeter

GUDID 06932562310348

Guangdong Biolight Meditech Co., Ltd.

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Primary Device ID06932562310348
NIH Device Record Key43c9382f-0933-4d5d-bedb-8bae778a09d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameFingertip Pulse Oximeter
Version Model NumberM50A
Company DUNS530120146
Company NameGuangdong Biolight Meditech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106932562310348 [Primary]

FDA Product Code

OCHOximeter, Infrared, Sporting, Aviation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-06
Device Publish Date2021-06-28

Devices Manufactured by Guangdong Biolight Meditech Co., Ltd.

06932562310355 - Fingertip Pluse Oximeter2024-04-08
06932562310362 - handheld monitor2024-04-08
06932562310317 - Fingertip Pulse Oximeter2021-11-10
06932562310324 - Fingertip Pulse Oximeter2021-11-10
06932562310348 - Fingertip Pulse Oximeter2021-07-06
06932562310348 - Fingertip Pulse Oximeter2021-07-06
06932562310331 - patient monitor2020-08-18
06932562310300 - Vital Signs Monitor2020-02-06
06932562310089 - Patient Monitor2020-02-06 The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological paramet

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