PJ Masks

Basic Information

• Brand Name: PJ Masks
• Primary DI: 00017276232837
• Version / Model: 017276980233
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-09-20
• Public Version: 2
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: e36850b8-d855-4e64-af69-d5b25e448eed
• Distribution End Date: 2023-08-31

Device Description

PJ Masks Bandages, fun designs, 3/4 IN x 3 IN (19 mm x 76 mm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44990	Skin-cover adhesive strip, non-antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20017276232831	GS1	case	24	Not in Commercial Distribution	2020-09-02
Primary	00017276232837	GS1
Package	00017276234534	GS1	box	5	Not in Commercial Distribution	2023-08-31
Package	20017276234538	GS1	case	24	Not in Commercial Distribution	2023-08-31
Unit of Use	60017276232839	GS1

Customer Contacts

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