Aero-Pro S Filter

GUDID 00841470110376

PULMODYNE INC

Microbial medical gas filter, single-use
Primary Device ID00841470110376
NIH Device Record Key40c32c5b-d174-46aa-85d6-9d1557a8f4af
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Pro S Filter
Version Model Number200102
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
GS100841470110376 [Primary]
GS110841470110373 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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

Devices Manufactured by PULMODYNE INC

10841470105454 - HMEF2024-07-09
10841470105461 - HMEF2024-07-09
10841470105478 - HMEF2024-07-09
10841470105485 - HMEF2024-07-09
10841470100718 - VT Select2023-04-18
10841470100749 - VT Select2023-04-18
10841470100770 - VT Select2023-04-18
10841470100794 - VT Select2023-04-18

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