Kerlix

Basic Information

• Brand Name: Kerlix
• Primary DI: 10884521068315
• Version / Model: 3338
• Catalog Number: 3338
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-06-30
• Public Version: 5
• Public Version Date: 2020-10-12
• Public Version Status: Update
• Public Device Record Key: 1b23e805-47aa-4f4e-99fc-3f1d445dc3c5
• Distribution End Date: 2019-08-21

Device Description

Super Sponge Saline Dressing

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMF	Bandage, liquid	General Hospital	880.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37298	Wound irrigation sterile saline	A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884521068319	GS1	CASE	192	Not in Commercial Distribution	2019-08-21
Primary	10884521068315	GS1
Package	20884521068312	GS1	PACK_OR_INNER_PACK	48	Not in Commercial Distribution	2019-08-21
Unit of Use	30884521083275	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify