AccessGUDID - DEVICE: Unimom (08809224872279)

GUDID

Device Identifier (DI) Information

Brand Name: Unimom
Version or Model: Opera eco
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UNIMOM CO.

Primary DI Number: 08809224872279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689057658 *Terms of Use

Device Description: The Opera eco is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast

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:	Yes
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?
38478	Breast pump, electric	A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGX	Pump, Breast, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190810	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 Humidity: less than 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 626507cc-b040-4f97-a7d4-27414e625c0f
Public Version Date: October 14, 2019
Public Version Number: 1
DI Record Publish Date: October 04, 2019