N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333241019
• Version / Model: 80230
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-01
• Public Version: 1
• Public Version Date: 2018-04-02
• Public Version Status: New
• Public Device Record Key: c4051c6b-c480-44ef-98b0-f4a7ad6f1549

Device Description

FLAT PNL MON ARM SET-COMPACT CART 80225

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	868.6175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47080	Endoscope transport trolley	A cart that is specially designed with dedicated instrument trays for the protective transport and short-term storage of endoscopes, their accessories, and other sensitive equipment. This trolley (cart) typically consists of a metal frame with plastic panels, and contains various numbers of platforms (e.g., trays that slot into the frame). It provides a safe and efficient environment for the organization of the endoscopes, minimizing their direct handling and contact with airborne contaminants, and allowing their visualization to distinguish those that have been sterilized from those that are contaminated.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333241019	GS1