ASP MEDICAL

Basic Information

• Brand Name: ASP MEDICAL
• Primary DI: 00840216122666
• Version / Model: PBALL045
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 1
• Public Version Date: 2023-08-14
• Public Version Status: New
• Public Device Record Key: 5601cd2e-6056-4301-81fb-f69263f7784d

Device Description

PEANUT BALL, INFLATABLE, 45 CM, PURPLE, UNINFLATED, LATEX FREE, 1EA/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: Yes
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41158	Balance ball exerciser	An elastic ball filled with air to a diameter of approximately 35 to 85 centimeters (14 to 34 inches) and intended to be used as an unstable surface on which to perform exercise to improve balance and posture. In contrast to exercising on a hard flat surface, the instability of the ball engages more muscles to maintain balance; it may also improve the strength and flexibility of muscles over time. The core body muscles, the abdominal and back muscles, are typically the focus of physical therapy programs that utilize this device which is also referred to as a Swiss ball, birth ball, Pilates ball, and body ball.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216122666	GS1