PRIMO

Basic Information

• Brand Name: PRIMO
• Primary DI: 00840216125018
• Version / Model: HC2SW
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-12
• Public Version: 1
• Public Version Date: 2024-01-22
• Public Version Status: New
• Public Device Record Key: 02ddab5c-0c47-4e89-b588-0a164a8d4cb8

Device Description

HEELCHECK BOOT/WEDGE KIT, WIDE BACK, SMALL, INCLUDES 1 EA ITEM HC2B, 1 EA ITEM ARW01, & 1 EA ITEM 33080 PACKAGED TOGETHER IN BAG, 1KIT/BG, 8BG/CS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11095	Foot cushion	A soft pillow or pad used to provide support and comfort to the user's feet, often during the treatment and/or prevention of musculoskeletal or circulatory disorders. The device may simply be used to alleviate pressure on the heels while the patient is sitting, or to slightly elevate the feet to reduce pressure and improve blood circulation in the lower extremity for the prevention of pressure sores and ulcers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216125018	GS1