VBMax36S, PF Testing Filter Labeled DR Burton 136604

GUDID 00817081028119

VBMax36S, Pulmonary Function Testing Filter Labeled DR Burton

A-M SYSTEMS, LLC

Pulmonary function testing filter/mouthpiece
Primary Device ID00817081028119
NIH Device Record Key816a488d-729d-4cbf-8c93-82d86acf0e9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVBMax36S, PF Testing Filter Labeled DR Burton
Version Model NumberVBMax36S, PF Testing Filter - 136604
Catalog Number136604
Company DUNS020275145
Company NameA-M SYSTEMS, LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081028102 [Primary]
GS100817081028119 [Package]
Contains: 00817081028102
Package: [100 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 Date2025-02-21
Device Publish Date2025-02-13

Devices Manufactured by A-M SYSTEMS, LLC

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00817081028072 - VBMax35s, PF Testing Filter Labeled DR Burton2025-02-21 VBMax35s, Pulmonary Function Testing Filter Labeled DR Burton
00817081028096 - VBMax35, PF Testing Filter2025-02-21 VBMax35, Pulmonary Function Testing Filter Labeled DR Burton
00817081028119 - VBMax36S, PF Testing Filter Labeled DR Burton2025-02-21VBMax36S, Pulmonary Function Testing Filter Labeled DR Burton
00817081028119 - VBMax36S, PF Testing Filter Labeled DR Burton2025-02-21 VBMax36S, Pulmonary Function Testing Filter Labeled DR Burton
00817081028133 - VBMax36E, PF Testing Filter2025-02-21 VBMax36E, Pulmonary Function Testing Filter Labeled DR Burton
00817081028157 - VBMax36, PF Testing Filter2025-02-21 VBMax36, Pulmonary Function Testing Filter Labeled DR Burton
00817081027952 - VBMax30S, PF Testing Filter Labeled DR Burton2025-02-04 VBMax30S, Pulmonary Function Testing Filter, Labeled DR Burton
00817081027976 - VBMax30E, PF Testing Filter2025-02-04 VBMax30E, Pulmonary Function Testing Filter, Labeled DR Burton

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