Aero-Sat HEPA

GUDID 10841470110342

PULMODYNE INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470110342
NIH Device Record Key12349a49-9938-4a2a-97dd-fd9765cf467c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Sat HEPA
Version Model Number102902
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
GS100841470110345 [Primary]
GS110841470110342 [Package]
Contains: 00841470110345
Package: [20 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-Sat HEPA]

10841470110342102902
10841470110335102901

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