AccessGUDID - DEVICE: Walgreens (00049022047945)

GUDID

Device Identifier (DI) Information

Brand Name: Walgreens
Version or Model: 283416
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WALGREEN CO.

Primary DI Number: 00049022047945
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008965063 *Terms of Use
Previous DI: 00049022701984

Device Description: WALG MENSTRUAL CUP MODEL 2. A menstrual cup is a feminine hygiene device that is inserted into the vagina during menstruation. Purpose is to collect menstrual fluid and prevent leaking onto clothes. Made of flexible medical grade silicone and shaped like a bell with a stem. Stem is used for insertion and removal. The bell-shaped cup seals against the vaginal wall just below the cervix. Every 4–12 hours, the cup is removed, emptied, rinsed, and reinserted. After each period, the cup should be boiled for at least 5 minutes and stored for use the next month.

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?
47728	Menstrual cup, non-latex, reusable	A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHE	Cup, Menstrual

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: 6de9c1a3-193b-42cb-84c2-6f74a21d90a6
Public Version Date: December 11, 2020
Public Version Number: 1
DI Record Publish Date: December 03, 2020