CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380097539
• Version / Model: 47-1704
• Catalog Number: 47-1704
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-12
• Public Version: 7
• Public Version Date: 2022-04-15
• Public Version Status: Update
• Public Device Record Key: 79b27b0f-091a-445f-8ef6-ec712be5d3b1
• Distribution End Date: 2022-04-15

Device Description

NPWT Bridging Set

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
OMP	negative pressure wound therapy Powered suction pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47408	Negative-pressure wound therapy system pump, electric	A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380097537	GS1	CASE	5	Not in Commercial Distribution	2022-04-15
Primary	10885380097539	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius