Disposable PFT Kit, VBMax35S w/ Rubber Nose Clip 187145

GUDID 00817081021752

Disposable Pulmonary Function Testing Kit, VBMax35S w/ Rubber Nose Clip

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081021752
NIH Device Record Keyd5a0ffeb-4fca-473b-9f7e-fadfb7a2b03a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable PFT Kit, VBMax35S w/ Rubber Nose Clip
Version Model NumberPFT Kit J, VBMax35S - 187145
Catalog Number187145
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081021745 [Primary]
GS100817081021752 [Package]
Contains: 00817081021745
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 Date2019-03-19
Device Publish Date2019-03-11

Devices Manufactured by A-M SYSTEMS, LLC

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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
00817081028331 - Disposable Blue PFT Nose Clip with Foam Pads2025-03-05 Disposable Blue PFT Nose Clip with Foam Pads, Labeled D R Burton
00817081028232 - Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style2025-03-03 Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton
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00817081028218 - PFT Nose Clip with Foam Pads2025-02-28 Disposable White Pulmonary Function Testing Nose Clip with Foam Pads
00817081028195 - Pulmonary Function Test Kit E2025-02-26 Pulmonary Function Test Kit E, VBMax35E W/ Foam Nose Clip & 1649, Labeled D R Burton

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