MEDICAL ACTION INDUSTRIES

Basic Information

• Brand Name: MEDICAL ACTION INDUSTRIES
• Primary DI: 10809160000656
• Version / Model: 80080B
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 5
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: ebc795cb-f370-47b8-973b-749a7c2ff52b
• Distribution End Date: 2019-09-14

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
OWL	Peripheral catheter insertion kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160000653	GS1		12	Not in Commercial Distribution	2019-09-14
Primary	10809160000656	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE AT ROOM TEMPERATURE
• Type: Special Storage Condition, Specify