Durex Air Close Fit Condom

GUDID 10302340876459

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex
Primary Device ID10302340876459
NIH Device Record Key5f54b1bb-6d66-4f1c-be3a-f04a040159b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurex Air Close Fit Condom
Version Model NumberCondom
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 Datetrue
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
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.
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]
GS110302340876459 [Package]
Contains: 00302340876452
Package: Carton [6 Units]
In Commercial Distribution
GS120302340876456 [Package]
Package: Case [8 Units]
In Commercial Distribution
GS140302340876450 [Unit of Use]
GS188302340876450 [Primary]

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 Date2023-04-04
Device Publish Date2023-03-27

On-Brand Devices [Durex Air Close Fit Condom]

10302340876459Condom
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10302340876435Condom
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