Medical Action Industries

Basic Information

• Brand Name: Medical Action Industries
• Primary DI: 10809160002537
• Version / Model: 4015
• 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: 2016-08-20
• Public Version: 4
• Public Version Date: 2020-01-09
• Public Version Status: Update
• Public Device Record Key: 30877efa-0756-445e-b0aa-9f52749a3821
• Distribution End Date: 2020-01-08

Device Description

Physician Formulary

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160002534	GS1		36	Not in Commercial Distribution	2020-01-08
Primary	10809160002537	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry; keep away from direct sunlight
• Type: Special Storage Condition, Specify