KamDoy Rx Skin Emulsion

Basic Information

• Brand Name: KamDoy Rx Skin Emulsion
• Primary DI: 00315455956612
• Version / Model: FP1012-1
• Company Name: ALVIX LABORATORIES, LLC
• Labeler DUNS: 962445925
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-15
• Public Version: 1
• Public Version Date: 2020-05-25
• Public Version Status: New
• Public Device Record Key: b2314fd0-18e4-4981-9c15-a70859a9559c

Device Description

KamDoy Rx Skin Emulsion is indicated as a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. KamDoy Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47671	Skin osmotic dressing, non-sterile	A non-sterile substance (e.g., ointment, cream, spray, impregnated material) intended to be topically applied to the skin (e.g., face, eyelids, extremities) and containing compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to expedite wound healing and skin re-epithelialization primarily through osmotic properties which absorb and retain water to create a moist environment; it does not include antimicrobial agents. It may be used to treat superficial and/or deep wounds (e.g., abrasions, lacerations, burns, surgical wounds, decubitus sores, ulcers). After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00315455956612	GS1

Premarket Submissions

Submission Number	Supplement Number
K141637	000