carePAC

GUDID 20850003042477

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

Extremity Care

Wound dressing kit, medicated

• Primary Device ID: 20850003042477
• NIH Device Record Key: 844724e5-7e0d-4455-b06f-7de9d621f6c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: carePAC
• Version Model Number: CX-MB01
• Company DUNS: 086365085
• Company Name: Extremity Care
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003042473 [Primary]
GS1	20850003042477 [Package]; Contains: 00850003042473; Package: Box [15 Units]; In Commercial Distribution

FDA Product Code

• MCY: Wound Dressing Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-14
• Device Publish Date: 2024-02-06

On-Brand Devices [carePAC]

• 10850003042180: Daily carePAC Collagen Powder & Antimicrobial 30PAC
• 10850003042173: Daily carePAC Collagen Matrix 30PAC
• 10850003042166: Daily carePAC Collagen Powder 30PAC
• 20850003042477: carePAC Large Size, Collagen XL Matrix w/ Bordered Fiber Gelling Gauze Kit contains: CP003 - 7
• 00850003042466: carePAC Large Size, Collagen Powders w/ Bordered Fiber Gelling Gauze Kit contains: CP001 (x2) -
• 10850003042456: carePAC Standard Size, Collagen Matrix w/ Non-Bordered Fiber Gelling Gauze Kit Contains: CP002
• 10850003042449: carePAC Standard Size, Collagen Powder w/ Non-Bordered Fiber Gelling Gauze Kit contains: CP001 -
• 10850003042432: carePAC Standard Size, Collagen Matrix w/ Bordered Fiber Gelling Gauze Single Kit contains: CP0
• 10850003042425: carePAC Standard Size, Collagen Powder w/ Bordered Fiber Gelling Gauze Kit contains: CP001 - 1
• 10850003042418: carePAC Standard Size, Collagen Matrix w/ Antimicrobial Gauze Kit contains: CP002 - 2x2 Collage
• 00850003042404: carePAC Standard Size, Collagen Powder w/ Antimicrobial Gauze Kit includes: CP001 - 1 g Collage