PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900 187266

GUDID 00817081028393

Pulmonary Function Test Kit I, VBMax36S w/ Foam Nose Clip and 164900, Labeled DR Burton

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081028393
NIH Device Record Key9149db14-3c2b-4d3b-8626-10ad0125ea78
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit I, VBMax36S w/ Foam Nose Clip and 164900
Version Model NumberPFT Kit I, VBMax36S - 187266
Catalog Number187266
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 Kittrue
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
Phone3606838300
Emailsales@a-msystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081028386 [Primary]
GS100817081028393 [Package]
Contains: 00817081028386
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 Date2025-04-10
Device Publish Date2025-04-02

Devices Manufactured by A-M SYSTEMS, LLC

00817081028416 - VBMax28, PF Testing Filter2025-04-11 VBMax28, Pulmonary Function Testing Filter Labeled DR Burton
00817081028430 - PFT Kit B, VBMax35 w/ Blue Foam Nose clip2025-04-11 Pulmonary Function Test Kit B, VBMax35 w/ Blue Foam Nose clip
00817081028393 - PFT Kit I, VBMax36S w/ Foam Nose Clip and 1649002025-04-10Pulmonary Function Test Kit I, VBMax36S w/ Foam Nose Clip and 164900, Labeled DR Burton
00817081028393 - PFT Kit I, VBMax36S w/ Foam Nose Clip and 1649002025-04-10 Pulmonary Function Test Kit I, VBMax36S w/ Foam Nose Clip and 164900, Labeled DR Burton
00817081028379 - PFT Kit B, VBMax482025-04-01 Pulmonary Function Test Kit B, VBMax48 w/ Rubber Nose clip and Tube Mouthpiece
00817081028355 - Pulmonary Function Test Kit E2025-03-10 Pulmonary Function Test Kit E, VBMax34E w/ Foam Nose Clip and Rubber Mouthpiece
00817081028270 - PFT Kit E, VBMax36E 2025-03-05 Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton
00817081028294 - Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton2025-03-05 Disposable White Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton
00817081028317 - Disposable Blue PFT Nose Clip with Rubber Pads2025-03-05 Disposable Blue Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton

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