Option Home w/ Side Stream, Disposable Nebulizer 166320

GUDID 00817081026450

Nebulizer, Compressor, Option Home w/ Side Stream, Disposable

A-M SYSTEMS, LLC

Nebulizing system delivery set, single-use
Primary Device ID00817081026450
NIH Device Record Keyfa25a1fc-a316-4806-85b4-540facd59186
Commercial Distribution StatusIn Commercial Distribution
Brand NameOption Home w/ Side Stream, Disposable Nebulizer
Version Model NumberOption Home w/ Side Stream, Disposable Nebulizer -
Catalog Number166320
Company DUNS020275145
Company NameA-M SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100817081026450 [Primary]

FDA Product Code

EPNPump, Nebulizer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

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