FDA.reportPublic FDA data

Adam and Eve

Primary DI
00810124861223
Brand
Adam and Eve
Company
Adam & Eve
Model
00810124861223
Device description
A&E PERSONAL LUBE 16 OZ
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150153000Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural LubricantPackage Solutions, LLC2015-10-20NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810124861223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810124861223008101248612238101248612230810124861223

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature away from direct sunlight

Contacts#

Phone, Email table
PhoneEmail
1-800-765-2326socialmedia@adameve.com

Regulatory Flags#

DUNS number
056405335
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810124862336Adam and Eve 008101248612852026-05-20
00810124861155Adam and Eve 008101248611552026-04-30
00810124861186Adam and Eve 008101248611862026-04-30
00810124861216Adam and Eve 008101248612162026-04-30
00810124861285Adam and Eve 008101248612852026-04-30
00810124861292Adam and Eve 008101248612922026-04-30
00810124861827Adam and Eve 008101248618272026-04-30
00810124862329Adam and Eve 008101248623292026-04-30

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Primary DI, Brand, Company table
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00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
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