Aero-Sat HEPA

GUDID 10841470110335

PULMODYNE INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470110335
NIH Device Record Keyd024c3c0-5118-482e-a6b8-cd03b4b16243
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Sat HEPA
Version Model Number102901
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
GS100841470110338 [Primary]
GS110841470110335 [Package]
Contains: 00841470110338
Package: [20 Units]
In Commercial Distribution

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

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