Aero-Sat Filter Pedi

GUDID 10841470110458

PULMODYNE INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470110458
NIH Device Record Keyd4fb66a7-8892-4cc2-9daa-2cb49168f025
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Sat Filter Pedi
Version Model Number101002
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
GS100841470110451 [Primary]
GS110841470110458 [Package]
Contains: 00841470110451
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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