AccessGUDID - DEVICE: CareOne Tampons (00041520039934)

GUDID

Device Identifier (DI) Information

Brand Name: CareOne Tampons
Version or Model: CA11812SO/1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ahold U.S.A., Inc.

Primary DI Number: 00041520039934
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 18
Labeler D-U-N-S® Number*: 170199058 *Terms of Use

Device Description: SCENTED REGULAR PLASTIC APPLICATOR TAMPONS

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
32683	Menstrual tampon, scented	A deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIL	Tampon, Menstrual, Scented, Deodorized

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050067	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: 4eab582a-f246-41fb-aad1-13259b6aa694
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 08, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10041520039931	12	00041520039934		In Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00004152003995 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES