DEVICE: DUREX Play Ring of Bliss Vibrating Ring and 1 Natural Rubber latex condom (00302340853781)
Device Identifier (DI) Information
DUREX Play Ring of Bliss Vibrating Ring and 1 Natural Rubber latex condom
Condom and General product
In Commercial Distribution
RB Health (us) LLC
Condom and General product
In Commercial Distribution
RB Health (us) LLC
Condom
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Basic male condom, Hevea-latex | A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HIS | CONDOM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K980319 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a cool dry place away from direct sunlight. Avoid excess heat, store in a cool dry place. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6ba9f269-a0c8-4956-98db-e1f32f3db161
December 13, 2018
4
August 31, 2017
December 13, 2018
4
August 31, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10302340853788 | 6 | 00302340853781 | In Commercial Distribution | Case | |
20302340853785 | 4 | 10302340853788 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)756-5488
xxx@xxx.xxx
xxx@xxx.xxx