Aero-T+

GUDID 10841470110083

PULMODYNE INC

Heat/moisture exchanger, single-use
Primary Device ID10841470110083
NIH Device Record Key7640ba05-f01e-4361-b7fb-2e8b0074c052
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-T+
Version Model Number301102
Company DUNS030619483
Company NamePULMODYNE INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100841470110086 [Primary]
GS110841470110083 [Package]
Contains: 00841470110086
Package: [30 Units]
In Commercial Distribution

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

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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