CareOne Tampons

GUDID 10041520039931

SCENTED REGULAR PLASTIC APPLICATOR TAMPONS

Ahold U.S.A., Inc.

Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented

• Primary Device ID: 10041520039931
• NIH Device Record Key: 4eab582a-f246-41fb-aad1-13259b6aa694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareOne Tampons
• Version Model Number: CA11812SO/1
• Company DUNS: 170199058
• Company Name: Ahold U.S.A., Inc.
• Device Count: 18
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00004152003995 [Unit of Use]
GS1	00041520039910 [Primary]
GS1	00041520039934 [Primary]
GS1	10041520039931 [Package]; Contains: 00041520039934; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050067

FDA Product Code

• HEB: Tampon, Menstrual, Unscented
• HIL: Tampon, Menstrual, Scented, Deodorized

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-08

On-Brand Devices [CareOne Tampons]

• 20041520864738: PLUS UNSCENTED CARDBOARD APPLICATOR TAMPONS
• 20041520864721: SUPER UNSCENTED CARDBOARD APPLICATOR TAMPONS
• 20041520864707: PLUS UNSCENTED CARDBORD APPLICATOR TAMPONS
• 10041520039955: MULTI PACK PLASTIC APPLICATOR TAMPONS
• 10041520039931: SCENTED REGULAR PLASTIC APPLICATOR TAMPONS
• 20041520864745: MULTI PACK CARDBOARD APPLICATOR TAMPONS
• 20041520864714: REGULAR UNSCENTED CARDBOARD APPLICATOR TAMPONS
• 20041520864691: SUPER UNSCENTED CARDBOARD APPLICATOR TAMPON
• 20041520864684: REGULAR UNSCENTED CARDBORD APPLICATOR TAMPONS
• 10041520039924: PLUS PLASTIC APPLICATOR UNSCENTED TAMPONS
• 10041520039917: SUPER UNSCENTED PLASTIC APPLICATOR TAMPONS
• 00041520039903: UNSCENTED REGULAR PLASTIC APPLICATOR TAMPONS