DEVICE: CareOne Tampons (00041520039934)

Device Identifier (DI) Information

CareOne Tampons
CA11812SO/1
In Commercial Distribution

Ahold U.S.A., Inc.
00041520039934
GS1

18
170199058 *Terms of Use
SCENTED REGULAR PLASTIC APPLICATOR TAMPONS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Menstrual tampon, scented A non-sterile plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. It is scented for aesthetic and deodorizing purposes to counter odorous smells resulting from the discharge. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HIL Tampon, Menstrual, Scented, Deodorized
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050067 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4eab582a-f246-41fb-aad1-13259b6aa694
July 06, 2018
3
September 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10041520039934 12 00041520039934 In Commercial Distribution CASE
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00004152003993 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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