PRIMO/ASP MEDICAL

Basic Information

• Brand Name: PRIMO/ASP MEDICAL
• Primary DI: 00840216117662
• Version / Model: UPA4057
• Company Name: Asp Global, LLC
• Labeler DUNS: 080361159
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-15
• Public Version: 3
• Public Version Date: 2023-02-23
• Public Version Status: Update
• Public Device Record Key: 3c438715-298c-4582-ad0b-77325003a709
• Distribution End Date: 2023-01-05

Device Description

UNDERPAD 40" * 57"

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: 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
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840216118355	GS1	Case	25	Not in Commercial Distribution	2023-01-05
Primary	00840216117662	GS1