carePAC

Basic Information

• Brand Name: carePAC
• Primary DI: 00850003042466
• Version / Model: CX-PB01
• 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: 79020a94-3484-4f57-b5ec-f24d5a2e5303

Device Description

carePAC Large Size, Collagen Powders w/ Bordered Fiber Gelling Gauze Kit contains: CP001 (x2) - 1 g Collagen Powder with Primary DI: 4052199578750 or 00366977311014 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
Primary	00850003042466	GS1

Customer Contacts

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

Storage Conditions

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