PFT Kit E, VBMax36E 189139

GUDID 00817081028270

Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081028270
NIH Device Record Keyb9282933-6c23-490a-99e7-13d3fce21f23
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit E, VBMax36E
Version Model NumberPFT Kit E, VBMax36E - 189139
Catalog Number189139
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081028263 [Primary]
GS100817081028270 [Package]
Contains: 00817081028263
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 Date2025-03-05
Device Publish Date2025-02-25

On-Brand Devices [PFT Kit E, VBMax36E ]

00817081022629PFT Kit E, Disposable, Qty 100, VBMax36E, W/ Blue Foam Nose Clips
00817081028270Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton

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