Aero-Pro HEPA Small Angled

GUDID 10841470109919

PULMODYNE INC

Microbial medical gas filter, single-use
Primary Device ID10841470109919
NIH Device Record Keyaf64c1fd-783c-4aca-87e9-6214021bbd29
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Pro HEPA Small Angled
Version Model Number20152
Company DUNS030619483
Company NamePULMODYNE INC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470109912 [Primary]
GS110841470109919 [Package]
Contains: 00841470109912
Package: [25 Units]
In Commercial Distribution

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-25

On-Brand Devices [Aero-Pro HEPA Small Angled]

0084147011001720151
1084147010991920152

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