Omron Air Filters for NE-C28 C28FL

GUDID 00073796328627

Omron Air Filters for Nebulizer NE-C28

Omron Healthcare, Inc.

Non-respiratory device ambient air filter
Primary Device ID00073796328627
NIH Device Record Key76ac6541-de15-4749-bb1e-674ec7d50a45
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Air Filters for NE-C28
Version Model NumberC28FL
Catalog NumberC28FL
Company DUNS054318779
Company NameOmron Healthcare, Inc.
Device Count5
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796286200 [Unit of Use]
GS100073796328627 [Primary]
GS110073796328624 [Package]
Package: Inner Carton [50 Units]
In Commercial Distribution
GS120073796328621 [Package]
Contains: 10073796328624
Package: Case [10 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2017-05-17

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