ASP MEDICAL

Basic Information

• Brand Name: ASP MEDICAL
• Primary DI: 00840216108028
• Version / Model: IAMRC02
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-15
• Public Version: 3
• Public Version Date: 2023-03-27
• Public Version Status: Update
• Public Device Record Key: 0117e118-fb53-4311-ae48-41530c3c483f

Device Description

BAG, PRESSURE INFUSER, 1000ML, MESH BACK, NON-MAGNETIC/MRI CONDITIONAL, 160 mm (W) x 418 mm (H), 5EA/BX, 5BX/CS (25EA/CS)

Device Characteristics

• Single Use: Yes
• 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: MR Conditional
• 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
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	880.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65172	Intravenous pressure infusor, manual, single-use	A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840216108028	GS1