DEVICE: CVS Health (00050428393338)

Device Identifier (DI) Information

CVS Health
BCVAC54
In Commercial Distribution
407760
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
00050428393338
GS1
August 31, 2018
1
062312574 *Terms of Use
Multi pack of 54 - 10 light/22 Regular/22 Super
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
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, unscented A non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HEB Tampon, Menstrual, Unscented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K001641 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
Device Size Text, specify: Absorbency
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Device Record Status

75557db2-6d76-43e3-be47-b9edb15c446b
July 06, 2018
4
September 20, 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
10050428393335 12 00050428393338 2018-08-31 In Commercial Distribution CASE
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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