Bacterial/Viral Depth Filter no Port

GUDID 10841470110953

PULMODYNE INC

Microbial medical gas filter, non-sterile, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use
Primary Device ID10841470110953
NIH Device Record Key282754e0-e482-49b8-8fec-88584aad14a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBacterial/Viral Depth Filter no Port
Version Model Number313-435
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
GS100841470110956 [Primary]
GS110841470110953 [Package]
Contains: 00841470110956
Package: [50 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 Date2020-04-27
Device Publish Date2020-04-17

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10841470100817 - VT Select2023-04-18
10841470106505 - BiTrac SE Select2022-04-05
10841470100282 - DART2022-04-04
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