carePAC

Basic Information

• Brand Name: carePAC
• Primary DI: 00850003042473
• Version / Model: CX-MB01
• Company Name: Extremity Care
• Labeler DUNS: 086365085
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-06
• Public Version: 1
• Public Version Date: 2024-02-14
• Public Version Status: New
• Public Device Record Key: 844724e5-7e0d-4455-b06f-7de9d621f6c8

Device Description

carePAC Large Size, Collagen XL Matrix w/ Bordered Fiber Gelling Gauze Kit contains: CP003 - 7x7 Collagen Matrix with Primary DI: 30612553024290 or 00366977377775 CP007 - Fiber Gell Dressing 7x7 with Primary DI: 4052199515175 OR CP008 - 8x8 Bordered with Primary DI: 4052199580494 CP010 - Conforming Stretch Bandage 6inx4.1yds with Primary DI: 10612553016239 or 10612553013238 CP000 - Gloves

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCY	Wound Dressing Kit	General Hospital	880.5075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34059	Wound dressing kit, medicated	A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850003042477	GS1	Box	15	In Commercial Distribution
Primary	00850003042473	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius