SelfTestLung

GUDID 04048675697718

Drägerwerk AG & Co. KGaA

Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator Lung physical simulator
Primary Device ID04048675697718
NIH Device Record Key72d4a719-4940-46b5-a1f9-172e6e6eb885
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelfTestLung
Version Model NumberMP20020
Company DUNS315578914
Company NameDrägerwerk AG & Co. KGaA
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104048675697718 [Primary]

FDA Product Code

BTCBag, Reservoir

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

Devices Manufactured by Drägerwerk AG & Co. KGaA

04048675436607 - Babyleo TN5002024-03-18
04048675556169 - Atlan A300 XL2023-09-29
04048675556176 - Atlan A3502023-09-29
04048675556183 - Atlan A350 XL2023-09-29
04048675556343 - Atlan A3002023-09-29
04048675697718 - SelfTestLung2023-09-07
04048675697718 - SelfTestLung2023-09-07
04048675389583 - VentStar humidifier chamber (N)2023-07-31
04048675411758 - VentStar Helix heated (N) Plus2023-07-31

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