Oxygen Concentrator

GUDID 06955623000019

SYSMED (CHINA) CO.,LTD

Stationary oxygen concentrator
Primary Device ID06955623000019
NIH Device Record Keyc1659b72-3c48-453b-acf8-9f33cad725ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxygen Concentrator
Version Model NumberM50
Company DUNS548237698
Company NameSYSMED (CHINA) CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106955623000019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25

On-Brand Devices [Oxygen Concentrator]

06955623000019M50
06955623000033MQ50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.