AccessGUDID - DEVICE: Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm (04713530090880)

GUDID

Device Identifier (DI) Information

Brand Name: Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm
Version or Model: mtf_M012L-sFx2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: mtf_M012L-sFx2
Company Name: MAYMOM LLC

Primary DI Number: 04713530090880
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657267337 *Terms of Use

Device Description: Maymom breast flange set made for Motif Medical containing two 21mm flanges compatible with Medela pumps, two valves, two membranes.

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?
61734	Breast pump support kit, reusable	A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHH	Breast Pump Kit

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
Special Storage Condition, Specify: -10 to 50 degree C, 20 - 95% humidity.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 71851919-a849-4887-b584-47b75e4a5cab
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020