FDA.reportPublic FDA data

IntiMD 8.5 fl oz Water Based Bottle

Primary DI
00850013300006
Brand
IntiMD 8.5 fl oz Water Based Bottle
Company
Oui Lab, Inc.
Model
IntiMD 8.5 fl oz Water Based Bottle
Catalog number
IDD11377
Device description
IntiMD 8.5 fl oz Water Based Bottle
Published
2023-04-10
Public version status
Update
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
K051295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051295000I-D GLIDEWestridge Laboratories, Inc.2006-02-15NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850013300007PackageGS112In Commercial Distribution
00850013300006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001330000730850013300007
00850013300006008500133000068500133000060850013300006

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.

Contacts#

Phone, Email table
PhoneEmail
(626) 315-8531support@intimd.com

Regulatory Flags#

DUNS number
121192588
Device count
1
Lot or batch
true
Expiration date on label
true

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00796494750216LL Water-Based 5mLCC Wellness LLCNUC2026-09-04
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00796494750230LL 3X Anal 5mLCC Wellness LLCNUC2026-09-04
00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
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