FDA.reportPublic FDA data

JO Cocktails - Pina Colada Flavored Lubricant - 2 floz 60 mL

Primary DI
10796494000271
Brand
JO Cocktails - Pina Colada Flavored Lubricant - 2 floz 60 mL
Company
CC Wellness LLC
Model
21001
Device description
Water-Based Personal Lubricant
Published
2022-09-08
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

Related Records

Product Codes

CodeName
NUCLubricant, Personal

Product Code Classifications

CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10796494000271PackageGS112In Commercial Distribution
00796494000274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1079649400027110796494000271
00796494000274007964940002747964940002740796494000274

GMDN Terms

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

Regulatory Flags

DUNS number
067692292
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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