AccessGUDID - DEVICE: Pump In Style Advanced (00020451570457)

GUDID

Device Identifier (DI) Information

Brand Name: Pump In Style Advanced
Version or Model: Advanced Personal Double Breast Pump with Batt
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 57045W
Company Name: Medela LLC

Primary DI Number: 00020451570457
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 052002029 *Terms of Use

Device Description: Powered Double Breast Pump

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):	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 [?]
K031614	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92a25f4a-5d65-4709-a7a0-64c7a446147e
Public Version Date: November 26, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2016