Omron Medication Bottle U22-3

GUDID 00073796512231

Medication Bottle for Vibrating Mesh Nebulizer NE-U22V

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use
Primary Device ID00073796512231
NIH Device Record Key19c9def3-b86c-4839-af03-0cbbc3bcd5a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Medication Bottle
Version Model NumberU22-3
Catalog NumberU22-3
Company DUNS054318779
Company NameOmron Healthcare, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-634-4350
Emailohiquality@omron.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796512231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

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 Date2017-05-17

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