AVID TRUCUSTOM

Basic Information

• Brand Name: AVID TRUCUSTOM
• Primary DI: 10809160144183
• Version / Model: VAMM036-02
• 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: 2017-04-04
• Public Version: 3
• Public Version Date: 2019-01-01
• Public Version Status: Update
• Public Device Record Key: 2239b1d5-913f-4c10-817a-4bf7f3a367f4
• Distribution End Date: 2018-05-23

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSB	Patient personal hygiene kit	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61949	Personal care kit	A collection of devices intended to be used by a patient for personal care needs during a stay in a healthcare institution. It typically contains items such as gown, slippers, cap, hair comb and toothbrush in a storage bag, and may also contain additional personal care products e.g., toothpaste, lotion and deodorant. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160144180	GS1		20	Not in Commercial Distribution	2018-05-23
Primary	10809160144183	GS1

Storage Conditions

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