PRIMO

Basic Information

• Brand Name: PRIMO
• Primary DI: 00840216113374
• Version / Model: AB201L
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-06
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: d5156973-1640-4529-87d0-70e7bdb6caab

Device Description

Abdominal Binder - Large (55"-63")

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
FSD	Binder, Abdominal	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47217	Abdominal binder, reusable	A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216113374	GS1