PrimaCare®

Basic Information

• Brand Name: PrimaCare®
• Primary DI: 00809958078419
• Version / Model: 71404LF
• Catalog Number: DUP71404LF
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-10-17
• Public Version: 2
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 7e199e42-a0c6-4159-9f08-c6ca322c0f07

Device Description

4 in X 5 yards premium elastic bandage with removable clips.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	BANDAGE, ELASTIC	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13369	Skin treatment/dressing-supportive limb/finger bandage, single-use	An elastic, tubular device intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury; it is not designed for tissue support/compression. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00809958078426	GS1	Case	12	In Commercial Distribution
Primary	00809958078419	GS1
Unit of Use	00809958078402	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4 in X 5 yards
Device Size Text, specify			10 cm X 4.5 m