AccessGUDID - DEVICE: AMEDA® (08809462731321)

GUDID

Device Identifier (DI) Information

Brand Name: AMEDA®
Version or Model: 102X01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CIMILRE CO .,LTD

Primary DI Number: 08809462731321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689851831 *Terms of Use

Device Description: This is powered breast pump intended to express and collect milk from the breasts of lactating women. user manual, so the user can use the device right after receiving them.

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?
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 [?]
Premarket Submission Number Not Available/Not Released

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 50 Degrees Celsius
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 739b81d4-f2c0-41b0-b850-5b9c4c561cf2
Public Version Date: November 15, 2021
Public Version Number: 2
DI Record Publish Date: January 04, 2019