PFT Kit F, VBMax36S w/ Foam Nose Clip 187147

GUDID 00817081022087

Pulmonary Function Testing Kit F, VBMax36S w/ Foam Nose Clip

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081022087
NIH Device Record Key280cc1f6-3b71-4e18-8d6d-6fda5f2b3065
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit F, VBMax36S w/ Foam Nose Clip
Version Model NumberPFT Kit F, VBMax36S - 187147
Catalog Number187147
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
GS100817081022070 [Primary]
GS100817081022087 [Package]
Contains: 00817081022070
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 Date2019-03-22
Device Publish Date2019-03-14

Devices Manufactured by A-M SYSTEMS, LLC

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