VBMax PFT Kit I 187165

GUDID 00817081022537

PFT Kit I, VBMax35S w/ Blue Foam Nose Clip and Rubber Mouthpiece

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081022537
NIH Device Record Key52092440-fe8f-4080-bba8-2eacab1b8ecc
Commercial Distribution StatusIn Commercial Distribution
Brand NameVBMax PFT Kit I
Version Model NumberVBMax PFT Kit I - 187165
Catalog Number187165
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
GS100817081022520 [Primary]
GS100817081022537 [Package]
Contains: 00817081022520
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 Date2019-08-13
Device Publish Date2019-08-05

Devices Manufactured by A-M SYSTEMS, LLC

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
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
00817081028256 - Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue Depressing2025-03-03 Breathebite Mouthpiece, Disposable, White, Thermoplastic, Tongue Depressing, D R Burton

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