Hallelubeyah

Primary DI
00869521000353
Brand
Hallelubeyah
Company
LOVABILITY LLC
Model
Lube-1
Device description
Our personal lubricant is an intimate moisturizer made with the vine extract of the New Zealand kiwifruit plant harvested from orchards in the Province of Auckland, New Zealand. Through a proprietary extraction process, the natural film like lubricant is collected, the composition of which is similar to that of what the body produces. Hallelubeyah personal lubricant is formulated to be a non sterile, non greasy, non sticky, non staining, viscous liquid with a pH range of 4.4 to 4.7 to match the vaginal region for the majority of a women’s cycle. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 1 ounce tubes.
Published
2020-06-12
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
K152646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152646000SYLK PERSONAL LUBRICANTToro Management, LLC Dba Sylk2016-03-11NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869521000353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869521000353008695210003538695210003530869521000353

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 Volume1Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-310-956-1432hello@lovabilityinc.com

Regulatory Flags#

DUNS number
116995012
Device count
1
Lot or batch
true
Expiration date on label
true

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