PFT Kit E, VBMax28E 189108

GUDID 00817081022490

PFT Kit E, Disposable, Qty 100, VBMax28E, W/ Blue Rubber Nose Clips

A-M SYSTEMS, LLC

Pulmonary function testing kit
Primary Device ID00817081022490
NIH Device Record Keya20daf6d-18a4-4863-802e-01f51dc2ff2a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFT Kit E, VBMax28E
Version Model NumberPFT Kit E, VBMax28E - 189108
Catalog Number189108
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
GS100817081022483 [Primary]
GS100817081022490 [Package]
Contains: 00817081022483
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 Date2019-05-13
Device Publish Date2019-05-03

On-Brand Devices [PFT Kit E, VBMax28E]

00817081022490PFT Kit E, Disposable, Qty 100, VBMax28E, W/ Blue Rubber Nose Clips
00817081021967Pulmonary Function Testing Kit E, VBMax28E

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