AccessGUDID - DEVICE: DUREX Pleasure Pack Condom (00302340302197)

GUDID

Device Identifier (DI) Information

Brand Name: DUREX Pleasure Pack Condom
Version or Model: Condom
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RB Health (us) LLC

Primary DI Number: 00302340302197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 081049410 *Terms of Use

Device Description: Condom

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

FDA Product Code

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Product Code	Product Code Name
HIS	CONDOM
MOL	Condom, synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020659	000
K072169	000
K902509	000
K980319	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

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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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bcad3fdb-8c7a-48ab-bd44-8e3049d17b8a
Public Version Date: December 13, 2018
Public Version Number: 4
DI Record Publish Date: September 20, 2016