Kendall

Basic Information

• Brand Name: Kendall
• Primary DI: 10884521551190
• Version / Model: 55577BAMDG
• Catalog Number: 55577BAMDG
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-27
• Public Version: 5
• Public Version Date: 2024-03-01
• Public Version Status: Update
• Public Device Record Key: c36c4f42-040b-47f8-8db5-d09918d96567
• Distribution End Date: 2025-12-31

Device Description

AMD Antimicrobial Gentle Border Foam Sacrum 0.5%; Polyhexamethylene Biguanide HCI (PHMB)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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: Yes
• 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
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884521551194	GS1	CASE	50	In Commercial Distribution	2025-12-31
Primary	10884521551190	GS1
Package	20884521551197	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution	2025-12-31

Device Sizes

Type	Value	Unit	Text
Length	7.5	Inch
Width	7.5	Inch
Device Size Text, specify			Pad, 5-1/4 x 4-3/4, IN;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No;AVOID DIRECT SUNLIGHT