DEVICE: DUREX Pleasure Pack Condom (00302340302197)

Device Identifier (DI) Information

DUREX Pleasure Pack Condom
Condom
In Commercial Distribution

RECKITT BENCKISER LLC
00302340302197
GS1

24
094405024 *Terms of Use
Condom
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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
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.
Basic male condom, synthetic polymer A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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.
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FDA Product Code

[?]
Product Code Product Code Name
HIS CONDOM
MOL Condom, synthetic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K020659 000
K072169 000
K902509 000
K980319 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bcad3fdb-8c7a-48ab-bd44-8e3049d17b8a
July 06, 2018
3
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
20302340302191 6 10302340302194 In Commercial Distribution Case
10302340302194 3 00302340302197 In Commercial Distribution Carton
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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: 40302340302195 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)756-5488
xxx@xxx.xxx
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