Omron Air Filters for NE-C30 C30FL

GUDID 00073796330620

Air Filters for NE-C30 Nebulizer

Omron Healthcare, Inc.

Non-respiratory device ambient air filter
Primary Device ID00073796330620
NIH Device Record Keydcbaa83f-2ee3-4aab-bdc2-1215afea331e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Air Filters for NE-C30
Version Model NumberC30FL
Catalog NumberC30FL
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 Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796306205 [Unit of Use]
GS100073796330620 [Primary]
GS110073796330627 [Package]
Package: Inner Carton [50 Units]
In Commercial Distribution
GS120073796330624 [Package]
Contains: 10073796330627
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

Devices Manufactured by Omron Healthcare, Inc.

10073796423121 - Extra large D-ring Cuff for Telehealth Blood Pressure Monitor2022-08-09
10073796893108 - Blood Pressure Monitor 2022-07-11 Telehealth Blood Pressure Monitor with extra large cuff compatibility.
00073796930004 - Blood Pressure Monitor 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch.
10073796711020 - Omron Upper Arm Blood Pressure Monitor2021-09-23 Upper arm blood pressure monitor - One-touch operation - 30 memory storage - irregular heartbeat detection
00073796507206 - No-Touch Forehead Thermometer2021-09-09 No-touch forehead thermometer with fast 1 second measurement and high temperature notification. 25 memory reading.
00073796745530 - Omron Blood Pressure Monitor2021-09-09 Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory stor
10073796931503 - Omron Scale with Bluetooth 2021-06-09 Weight scale with wireless communication - Bluetooth
10073796842908 - Omron Digital Weight Scale2021-02-09 Omron Digital Weight Scale Telehealth with Bluetooth - 20-550 lbs.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.