PFT Kit I, VBMax31S 187121

GUDID 00817081027587

Pulmonary Function Test Kit I, VBMax31S, with White Foam Nose Clip & Rubber Mouthpiece

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081027587
NIH Device Record Keyb212436c-445a-4ef9-b046-575477bfb6c3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit I, VBMax31S
Version Model NumberPFT Kit I, VBMax31S - 187121
Catalog Number187121
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
Phone3606838300
Emailsales@a-msystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081027570 [Primary]
GS100817081027587 [Package]
Contains: 00817081027570
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 Date2023-05-25
Device Publish Date2023-05-17

Devices Manufactured by A-M SYSTEMS, LLC

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00817081027990 - VBMax30, PF Testing Filter2025-02-04 VBMax30, Pulmonary Function Testing Filter, Labeled DR Burton
00817081028010 - VBMax34S, PF Testing Filter Labeled DR Burton2025-02-04 VBMax34S, Pulmonary Function Testing Filter Labeled DR Burton
00817081028034 - VBMax34E, PF Testing Filter Labeled DR Burton2025-02-04 VBMax34E, Pulmonary Function Testing Filter Labeled DR Burton
00817081027914 - 3 Liter Aluminum Calibration Syringe w/ Adapter2024-11-15 3 Liter Aluminum Calibration Syringe w/ Adapter
00817081027884 - PFT Kit A, 28MM O.D2024-11-01 Pulmonary Function Test Kit A, 28MM O.D., W/Foam Nose Clip & Rubber Mouthpiece
00817081027907 - PFT Kit J, VBMax36S2024-11-01 Pulmonary Function Test Kit J, VBMax36S with Blue Foam Nose Clip

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