FDA.reportPublic FDA data

BioNourish Vaginal Gel

Primary DI
30893268000681
Brand
BioNourish Vaginal Gel
Company
GOOD CLEAN LOVE, INC.
Model
2oz
Catalog number
200602
Published
2022-04-14
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
K193448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193448000BioNourish LubricantGood Clean Love, Inc.2020-03-12NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30893268000681PackageGS124In Commercial Distribution
00893268000680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3089326800068130893268000681
00893268000680008932680006808932680006800893268000680

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-344-4483info@goodcleanlove.com

Regulatory Flags#

DUNS number
153909531
Device count
1
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
true
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
00850014621070Rehydrate Vaginal Gel5 mL2006012022-04-14
00893268000673Regenesis Fertility Lubricant2oz2004022022-04-12
00893268000680Rehydrate Vaginal Gel2oz2006022022-04-14
00893268000802Regenesis Fertility Lubricant5mL2004012023-04-03
00850044065172Naked Coconut1.5oz7006502025-06-24
00850044065219Naked Coconut3ozE700750, C7007502025-06-24
00893268000253BioNude Ultra Sensitive Personal Lubricant3oz2007042022-04-12
00893268000604Almost Naked4oz.2001042016-10-13
00893268000222Restore Moisturizing Vaginal Gel2oz.5001022017-09-25
00893268000109Almost Naked1.5oz.2001052016-10-13
00850014621773Liquid Lubricant5 mL2005002022-05-18
00850014621780Hybrid Lubricant5 mL2005012022-05-18
00893268000260BioNude Ultra Sensitive Personal Lubricant5 mL2007052022-04-12
00893268000710Restore Moisturizing Vaginal Gel5 mL5001012022-04-12
00850014621940Almost Naked Hint of Mint1.69oz7003502023-07-05
00893268000987Almost Naked5ml2001032016-10-13
00850014621568Hybrid Lubricant1.69oz7002502022-05-09
00893268000239Guilty Pleasure / Cinnamon Vanilla1.5oz.2003052016-10-13
00893268000598Guilty Pleasure / Cinnamon Vanilla4oz.2003042016-10-13
00893268000031Guilty Pleasure / Cinnamon Vanilla5ml 2001062016-10-13

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