Acetaminophen

Basic Information

• Brand Name: Acetaminophen
• Primary DI: 00628063401291
• Version / Model: 03R7420
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-08
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 0f9f3333-e2a0-4142-bedc-0d3f9f33c534

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
59051	Acetaminophen IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of acetaminophen in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628063401291	GS1