AH! YES COCO Personal Lubricant

Basic Information

• Brand Name: AH! YES COCO Personal Lubricant
• Primary DI: 05060104171506
• Version / Model: AMOB5AC30
• Company Name: BIO-TECH LUBRICANTS LIMITED
• Labeler DUNS: 219852776
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-22
• Public Version: 1
• Public Version Date: 2023-11-30
• Public Version Status: New
• Public Device Record Key: acd1919e-385c-4b62-babc-099b6347156e

Device Description

AH! YES COCO 5ml pre-filled applicators x 30

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUC	Lubricant, Personal	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47899	Vaginal mucosa protection dressing	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060104171506	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K191411	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius