FDA.reportPublic FDA data

AH! YES VM Vaginal Moisturizer

Primary DI
05060104171056
Brand
AH! YES VM Vaginal Moisturizer
Company
BIO-TECH LUBRICANTS LIMITED
Model
AMVM5AC6
Device description
AH! YES VM Vaginal Moisturizer 5ml Applicators x 6
Published
2023-11-22
Public version status
New
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
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060104171056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060104171056050601041710565060104171056

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal mucosa protection dressingA substance (e.g., gel, cream, suppository) containing various compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to be applied in and around the vagina to: 1) promote and/or expedite the healing, re-epithelialization, and/or soothing/lubrication of dry, injured, atrophic, or irritated vaginal mucosa; and/or 2) function as barrier to prevent adherence of pathogenic microorganisms (especially mycotic) to the vulvo-vaginal mucosa. It is intended for use in the home or healthcare facility to manage procedure-related injury (e.g., childbirth, surgery, radiotherapy), menopause, or various pathologies (e.g., vulvovaginitis). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-777-0125hello@ahyes.org

Regulatory Flags#

DUNS number
219852776
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060104170998AH! YES WB Personal LubricantAMW50C2023-11-22
05060104171001AH! YES WB Personal LubricantAMW100C2023-11-22
05060104171018AH! YES WB Personal LubricantAMW150C2023-11-22
05060104171025AH! YES WB Personal LubricantAMW5AC62023-11-22
05060104171032AH! YES WB Personal LubricantAMW5AC302023-11-22
05060104171049AH! YES VM Vaginal MoisturizerAMVM100C2023-11-22
05060104171063AH! YES VM Vaginal MoisturizerAMVM5AC302023-11-22
05060104171070AH! YES OB Personal LubricantAMOB40C2023-11-22
05060104171087AH! YES OB Personal LubricantAMOB80C2023-11-22
05060104171094AH! YES OB Personal LubricantAMOB140C2023-11-22
05060104171490AH! YES COCO Personal LubricantAMOB5AC62023-11-22
05060104171506AH! YES COCO Personal LubricantAMOB5AC302023-11-22
05060104171636AH! YES WB Personal LubricantAMW7S2023-11-22
05060104171643AH! YES OB Personal LubricantAMOB7S2023-11-22
05060104171650AH! YES VM Vaginal MoisturizerAMVM7S2023-11-22

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