FDA.reportPublic FDA data

DUREX® Air Regular Fit; DUREX® Air

Primary DI
00067981087970
Brand
DUREX® Air Regular Fit; DUREX® Air
Company
RECKITT BENCKISER LLC
Model
00067981087970
Device description
Durex Air Regular Fit Condom 3ct. Durex Air Condom 3ct.
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222068000Durex Penck III RegularRb Health (Us), LLC2022-10-12HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10067981087977PackageGS148In Commercial Distribution
00067981087970PrimaryGS10
99067981087981Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1006798108797710067981087977
00067981087970000679810879700679810879700067981087970
9906798108798199067981087981

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Contacts#

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

Regulatory Flags#

DUNS number
094405024
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00067981087352KY UltraGel Personal Lubricant000679810873522016-09-20
00067981087376KY UltraGel Personal Lubricant000679810873762016-09-20
00067981087987DUREX® Air Regular Fit; DUREX® Air000679810879872025-03-13
00067981087994DUREX® Air Regular Fit; DUREX® Air000679810879942025-03-13
00067981089127KY Personal Lubricant Jelly000679810891272025-12-09
00067981089486KY Warming Jelly000679810894862025-12-09
00067981952292KY Intense Pleasure Gel000679819522922025-12-09
00067981963496KY Tingling Lubricant000679819634962019-04-22
00067981993691KY Personal Lubricant Jelly000679819936912025-12-09
00067981993738KY Personal Lubricant Jelly000679819937382025-12-09
00067981993783K-Y® Hydrablend000679819937832025-07-10
00067981993967KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
00067981993974KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
00067981993981KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981994155KY Warming Liquid Lubricant000679819941552025-06-01
00067981994162KY Yours & Mine Couples Lubricant000679819941622025-06-01
00302340090001DUREX Tropical Condoms003023400900012025-03-13
00302340129008DUREX Extra Sensitive Condom003023401290082025-03-13
00302340241007DUREX Extra Sensitive Condom003023402410072025-03-13
00302340853279DUREX Performax Intense Condom003023408532792025-03-13

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Primary DI, Brand, Company table
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00726893120945One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120952One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120969One LuxGLOBAL PROTECTION CORP.HIS2026-06-08
00810124865085Adam and Eve hard riderGLOBAL PROTECTION CORP.HIS2026-06-08
00860015576620Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
10860015576603Swoon Ultra ThinGLOBAL PROTECTION CORP.HIS2026-06-08
00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHHIS2026-01-27
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08859798107130LifeStylesSURETEX LIMITED - BRANCHHIS2025-07-30
08859798106577LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20
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08859798106737LIFESTYLESSURETEX LIMITED - BRANCHHIS2025-06-20