Mesh Cap U100-4

GUDID 10073796011045

Mesh Cap for NE-U100 (MicroAir Vibrating Mesh Nebulizer)

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use
Primary Device ID10073796011045
NIH Device Record Key6b3684d1-3898-4af8-b2b0-837fcca7c0b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMesh Cap
Version Model NumberU100-4
Catalog NumberU100-4
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
GS100073796011048 [Primary]
GS110073796011045 [Package]
Contains: 00073796011048
Package: Case [400 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-03
Device Publish Date2018-10-31

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