AndoFlex UBZ

Basic Information

• Brand Name: AndoFlex UBZ
• Primary DI: 10724004620886
• Version / Model: 4"W/IN TN 3
• Catalog Number: ASP-8830UBZ-TN
• Company Name: Andover Healthcare, Inc.
• Labeler DUNS: 088528245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-05
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6552e3c0-40f0-4353-b2ae-860161fd473d

Device Description

Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. AndoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. 4"W/IN TN 3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58983	Compression bandaging kit	A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00724004620889	GS1	Case	8	In Commercial Distribution
Primary	10724004620886	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit