DUREX Classic XXL and DUREX Classic Condom

GUDID 00302340300452

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID00302340300452
NIH Device Record Key29812b79-7b16-4510-bf12-c7de234b460f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUREX Classic XXL and DUREX Classic Condom
Version Model NumberCondom
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx
Phone+1(800)756-5488
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100302340300438 [Package]
Contains: 99302340300456
Package: Carton [12 Units]
In Commercial Distribution
GS100302340300452 [Package]
Contains: 99302340300456
Package: Carton [3 Units]
In Commercial Distribution
GS120302340300456 [Package]
Package: Case [144 Units]
In Commercial Distribution
GS150302340300433 [Package]
Contains: 00302340300438
Package: Case [18 Units]
In Commercial Distribution
GS199302340300456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCONDOM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-10-02
Device Publish Date2023-07-13

Devices Manufactured by RB Health (us) LLC

00302340995931 - Durex Intense XL2025-09-09 10 ct. Durex Intense XL Nitrile Condom
50302340995998 - Durex Intense XL2025-09-09 3 ct. Durex Intense XL Nitrile Condom
50302340996001 - Durex Intense XL2025-09-09 24 ct. Durex Intense XL Nitrile Condom
50302340996018 - Durex Intense Ultra Lube2025-09-09 10 ct. Durex Intense Ultra Lube Nitrile Condom
50302340996025 - Durex Intense Ultra Lube2025-09-09 24 ct. Durex Intense Ultra Lube Nitrile Condom
10067981993780 - K-Y® Hydrablend 2025-07-18 1.5 oz. KY Hydrablend Hybrid Personal Lubricant
00067981993790 - K-Y® Hydrablend 2025-07-18 4.5 oz. KY Hydrablend Hybrid Personal Lubricant
00067981087116 - KY Warming Liquid Lubricant2025-06-09 Personal Lubricant - 2.4oz.

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