PFT KIT J, VBMax34S w/ Blue Rubber Nose clip 187174

GUDID 00817081028539

PFT KIT J, VBMax34S w/ Blue Rubber Nose clip

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081028539
NIH Device Record Key7bfff88d-e9ff-431a-9592-667d49ccbdb1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT KIT J, VBMax34S w/ Blue Rubber Nose clip
Version Model NumberPFT KIT J, VBMax34S - 187174
Catalog Number187174
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081028522 [Primary]
GS100817081028539 [Package]
Contains: 00817081028522
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 Date2025-07-03
Device Publish Date2025-06-25

Devices Manufactured by A-M SYSTEMS, LLC

00817081028515 - VBMAX34, DISPOSABLE PF TESTING FILTER2025-07-03 VBMAX34, DISPOSABLE PF TESTING FILTER
00817081028539 - PFT KIT J, VBMax34S w/ Blue Rubber Nose clip2025-07-03PFT KIT J, VBMax34S w/ Blue Rubber Nose clip
00817081028539 - PFT KIT J, VBMax34S w/ Blue Rubber Nose clip2025-07-03 PFT KIT J, VBMax34S w/ Blue Rubber Nose clip
00817081028492 - VBMax34, PF Testing Filter Labeled DR Burton2025-06-11 VBMax34, Pulmonary Function Testing Filter Labeled DR Burton
00817081028478 - PFT Kit B, VBMax352025-05-20 Pulmonary Function Testing Kit B, VBMax35 with Blue Rubber Pad Nose Clip
00817081028454 - PFT Kit J, VBMax31S2025-05-12 Pulmonary Function Testing Kit J, VBMax31S with White Rubber Pad Nose Clip
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 1649002025-04-10 Pulmonary Function Test Kit I, VBMax36S w/ Foam Nose Clip and 164900, Labeled DR Burton

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.