ESENTA

Basic Information

• Brand Name: ESENTA
• Primary DI: 00768455193073
• Version / Model: 423392
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 4cf17b07-a534-4405-b08c-403f7ea20a66

Device Description

Esenta™ Skin Barrier Wipe (25EA/PK; 20PK/CS) Non-sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
EXE	PROTECTOR, OSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58978	Synthetic-polymer liquid barrier dressing	A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455193070	GS1		20	In Commercial Distribution
Primary	00768455193073	GS1
Unit of Use	00768455197316	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	25.00000	Milliliter