DUREX Classic XXL and DUREX Classic Condom

GUDID 00302340300452

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

Primary Device ID	00302340300452
NIH Device Record Key	29812b79-7b16-4510-bf12-c7de234b460f
Commercial Distribution Status	In Commercial Distribution
Brand Name	DUREX Classic XXL and DUREX Classic Condom
Version Model Number	Condom
Company DUNS	081049410
Company Name	RB Health (us) LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 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 Agency	Device ID
GS1	00302340300438 [Package] Contains: 99302340300456 Package: Carton [12 Units] In Commercial Distribution
GS1	00302340300452 [Package] Contains: 99302340300456 Package: Carton [3 Units] In Commercial Distribution
GS1	20302340300456 [Package] Package: Case [144 Units] In Commercial Distribution
GS1	50302340300433 [Package] Contains: 00302340300438 Package: Case [18 Units] In Commercial Distribution
GS1	99302340300456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113061

FDA Product Code

HIS

CONDOM

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2024-10-02
Device Publish Date	2023-07-13

Devices Manufactured by RB Health (us) LLC

00302340300490 - DUREX® Pleasure Pack	2025-03-28 Durex Pleasure Pack Condom - 3ct. Contains: Extra Sensitive Thin - 1ct. Extra Sensitive Stimulating - 1ct. Performax Intense -
50302340989331 - DUREX® Pleasure Pack	2025-03-28 Durex Pleasure Pack Condom - 42ct. Contains: Extra Sensitive Thin - 11ct. Extra Sensitive Smooth - 10ct. Extra Sensitive Stimul
50302340995691 - DUREX® Adventure Pack	2025-03-28 Durex Adventure Pack Condom - 144ct. Contains: Extra Sensitive Smooth - 48ct. Extra Sensitive Stimulating - 48ct. Performax Int
10067981087984 - DUREX® Air Regular Fit; DUREX® Air	2025-03-21 Durex Air Regular Fit Condom 10ct. Durex Air Condom 10ct.
50302340876570 - DUREX® Air Regular Fit; DUREX® Air	2025-03-21 Durex Air Regular Fit Condom 36ct. Durex Air Condom 36ct.
20302340090005 - DUREX Tropical Condoms	2025-03-21 DUREX Tropical Condoms 3ct.
50302340129003 - DUREX Extra Sensitive Condom	2025-03-21 Extra Sensitive Thin Condom 3ct. Extra Sensitive Thin Regular Fit 3ct.
50302340876600 - DUREX Extra Sensitive Condom	2025-03-21 Extra Sensitive Thin Condom 24ct. Extra Sensitive Thin Regular Fit 24ct.