FDA.reportPublic FDA data

BioNude Ultra Sensitive Personal Lubricant

Primary DI
00893268000253
Brand
BioNude Ultra Sensitive Personal Lubricant
Company
GOOD CLEAN LOVE, INC.
Model
3oz
Catalog number
200704
Device description
Personal lubricant for vaginal/penile application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication.
Published
2022-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850014621057PackageGS124In Commercial Distribution
40893268000251PackageGS124In Commercial Distribution
50893268000258PackageGS196In Commercial Distribution
00893268000253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001462105730850014621057
4089326800025140893268000251
5089326800025850893268000258
00893268000253008932680002538932680002530893268000253

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
541-344-4483info@goodcleanlove.com

Regulatory Flags#

DUNS number
153909531
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
30893268000230Guilty Pleasure / Cinnamon Vanilla1.5oz.2003052016-10-13

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