FDA.report

Walgreens

Primary DI
00049022701984
Brand
Walgreens
Company
WALGREEN CO.
Model
656620
Device description
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.
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HHECup, Menstrual

Product Code Classifications

CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10049022701981PackageGS112In Commercial Distribution
00049022701984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902270198110049022701981
00049022701984000490227019840490227019840049022701984

GMDN Terms

TermDefinition
Menstrual cup, non-latex, reusableA 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 normally available [non-prescription] over-the-counter (OTC). It 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.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

Regulatory Flags

DUNS number
008965063
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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