AccessGUDID - DEVICE: Gen.2 Silicone Breast Pump

GUDID

Device Identifier (DI) Information

Brand Name: Gen.2 Silicone Breast Pump - 100ml
Version or Model: MHK011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THINK GREEN LIMITED

Primary DI Number: 09420060201031
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 595005923 *Terms of Use

Device Description: A manual, silicone breast pump that uses natural suction to draw out milk from the breast or collect let-down during breastfeeding

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
38477	Breast pump, manual	A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGY	Pump, Breast, Non-Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91609b24-13fa-450f-9a31-2c58f388ca4e
Public Version Date: December 18, 2024
Public Version Number: 1
DI Record Publish Date: December 10, 2024