Hemovac® Wound Drainage System

Basic Information

• Brand Name: Hemovac® Wound Drainage System
• Primary DI: 00889024370265
• Version / Model: 00-1535-000-10
• Catalog Number: 00-1535-000-10
• Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
• Labeler DUNS: 137354267
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: 9c17ee4e-90db-4500-af3b-2ac07dc7002e

Device Description

Directional Flow Control

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48125	Antibiotic directional flow irrigation system	A sterile device assembly designed to enable change in the direction of the flow of an antibiotic solution for distribution throughout the infected area of a wound, along with continual flushing of wound drains. The device functions as a directional flow control and typically consists of a prefabricated assembly of tubing, manually-operated clamps, and connectors. It is connected to the wound tubes, the antibiotic solution bag, and a wound evacuator. It is typically used as a supplement to a wound drainage kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00889024378711	GS1	Box	10	In Commercial Distribution
Primary	00889024370265	GS1

Customer Contacts

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