DUREX Air Close Fit Condom

GUDID 50302340876457

DUREX Air Close Fit Condom 3ct.

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID50302340876457
NIH Device Record Key5b4fcfff-7343-4bbb-aea5-d9930eeb9e73
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUREX Air Close Fit Condom
Version Model Number00302340876452
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count3
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100302340876452 [Primary]
GS150302340876457 [Package]
Contains: 00302340876452
Package: Case [48 Units]
In Commercial Distribution
GS199302340876449 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCONDOM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-21
Device Publish Date2025-03-13

On-Brand Devices [DUREX Air Close Fit Condom]

10302340876459Condom
10302340876442Condom
10302340876435Condom
99302340876449Condom
50302340876457DUREX Air Close Fit Condom 3ct.
50302340876440DUREX Air Close Fit Condom 10ct.
50302340876433DUREX Air Close Fit Condom 24ct.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.