FDA.reportPublic FDA data

Aqua Lube

Primary DI
10016169510257
Brand
Aqua Lube
Company
MAYER LABORATORIES, INC.
Model
Aqua Lube Natural Packets
Catalog number
51025
Device description
Personal Lubricant 144 ct
Published
2023-11-06
Public version status
New
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
NUCLubricant, personal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110325000AQUA LUBEMayer Laboratories, Inc.2011-12-08NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10016169510257PackageGS18In Commercial Distribution
20016169510254PackageGS1144In Commercial Distribution
00016169510250PrimaryGS10
30054003510258Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001616951025710016169510257
2001616951025420016169510254
00016169510250000161695102500161695102500016169510250
3005400351025830054003510258

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(510)229-5300davidm@mayerlabs.com

Regulatory Flags#

DUNS number
175425982
Device count
144
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016169010248ThinKimono10242025-10-06
00016169030130MAXX Large FlareKimono MAXX030132025-10-06
00016169050404MicroThinKimono50402025-10-06
00016169070242MicroThin Ribbed + Sensi-DotsKimono70242025-10-06
00016169088032Kimono MicroThin XLKimono Microthin XL Condoms088032025-10-06
00016169114090Callvin RegularCallvin Latex Condom114092025-10-06
00016169114106Callvin GoldCallvin Latex Condom114102025-10-06
00016169114113PlaygroundPlayground Condoms114112025-10-06
00016169700057Nauox Yin YangNauox Yin Yang700052025-10-06
00016169700064Nauox Holy HoneyNauox Holy Honey700062025-10-06
00016169700071Nauox Dulce DreamsNauox Dulce Dreams700072025-10-06
00016169700088Nauox Sweet HavenNauox Sweet Haven700082025-10-06
00016169700095Naoux Agave NectarNaoux Agave Nectar700092025-10-06
00016169700194Femme GlydeFemme Glide Natural Lubriant700192025-10-06
00198715811087Kindra V LubeKindra Silicone Lubricant700182025-10-06
06279870714292NixitNixit Natural Lubricant700042023-11-03
00860004693543Pill ClubPeriod Care Reg Pads999-001-042022-02-09
00860004693550Pill ClubPeriod Care Super Pads999-001-052022-02-09
00860004693567Pill ClubPeriod Care Combo Pads999-001-062022-02-09
00860004693598Pill ClubPeriod Care Combo Tampons&Pads999-001-092022-02-09

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