Areo-Pro

GUDID 10841470110366

PULMODYNE INC

Microbial medical gas filter, non-sterile, single-use
Primary Device ID10841470110366
NIH Device Record Keyc4883dfa-ab32-4c58-828b-f58ba97a2dc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreo-Pro
Version Model Number200302
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
GS100841470110369 [Primary]
GS110841470110366 [Package]
Contains: 00841470110369
Package: [25 Units]
In Commercial Distribution
GS120841470110363 [Package]
Package: [250 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 Date2020-05-18
Device Publish Date2020-05-08

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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