AccessGUDID - DEVICE: Omron Air Filters for NE-C30 (00073796330620)

GUDID

Device Identifier (DI) Information

Brand Name: Omron Air Filters for NE-C30
Version or Model: C30FL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C30FL
Company Name: Omron Healthcare, Inc.

Primary DI Number: 00073796330620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 054318779 *Terms of Use

Device Description: Air Filters for NE-C30 Nebulizer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11711	Non-respiratory device ambient air filter	A filter designed to be installed in a non-respiratory device to clean the ambient air that passes through it to facilitate device operation/management. It is composed of tightly woven materials which remove particulates/impurities and, depending on how the device is installed, reduce the concentration of impurities to or from the air. It is typically used in devices that draw in ambient air for use as part of their function (e.g., to cool electrical motors, liquidize air as in a flotation therapy bed, wash/disinfect surgical instruments), or devices that, having used the air as a drive gas, exhaust it into a room via the filter. After installation, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060811	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcbaa83f-2ee3-4aab-bdc2-1215afea331e
Public Version Date: February 06, 2020
Public Version Number: 4
DI Record Publish Date: May 17, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10073796330627	50	00073796330620		In Commercial Distribution	Inner Carton
20073796330624	10	10073796330627		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00073796306205 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-634-4350
Email: ohiquality@omron.com

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