PFT Kit A w/ Foam Noseclip 180054

GUDID 00817081021271

PFT Kit A, 35mm Kit with Foam Noseclip

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081021271
NIH Device Record Key91843423-1fa3-48a5-b4b8-0aacdcdeb8e5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit A w/ Foam Noseclip
Version Model NumberPFT Kit A w/ Foam Noseclip - 180054
Catalog Number180054
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com
Phone3606838300
Emailsales@a-msystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817081021264 [Primary]
GS100817081021271 [Package]
Contains: 00817081021264
Package: [50 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-05

Devices Manufactured by A-M SYSTEMS, LLC

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00817081027846 - PFT Kit I, VBMax 34s with Nose Clip and Mouthpiece2024-10-16 Pulmonary Function Test Kit I, VBMax34S, w/ Blue Rubber Nose Clips & Rubber Mouthpiece
00817081027860 - PFT KIT J, VBMax35S, w/ Foam Nose Clip2024-10-16 Pulmonary Function Test Kit J, VBMax35S, w/ Foam Nose Clip
00817081027822 - PFT Kit A, 48 MM O.D.2024-09-30 PFT Kit A, 48 MM O.D.
00817081027808 - PFT KIT F, VBMax36S w/ Rubber Nose Clips2024-09-16 Pulmonary Function Test Kit F, VBMax36S with Rubber Nose Clips
00817081027785 - PFT Kit I, VBMax35S, w/ White Foam Nose Clips2024-07-18 Pulmonary Function Test Kit I, VBMax35S, w/ White Foam Nose Clips

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