M9264-PCD-200, Pressure Tube

Basic Information

• Brand Name: M9264-PCD-200, Pressure Tube
• Primary DI: 06420099001124
• Version / Model: M9264-PCD-200
• Company Name: Medikro Oy
• Labeler DUNS: 369263660
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-29
• Public Version: 1
• Public Version Date: 2019-12-09
• Public Version Status: New
• Public Device Record Key: 27739628-6bd0-4c42-a044-6a7e079aebfb

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: No
• Has Lot/Batch Number: Yes
• 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
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61731	Spirometry/pulmonary function pressure tube	A non-sterile plastic tube intended to conduct airflow pressure from a breathing mouthpiece to a parent device (e.g., spirometer) during pulmonary function testing (e.g., respiratory gas volume and flow). It is intended to function with a separate spirometry device and/or a pulmonary function analyser and is not intended to be integrated into a breathing circuit during respiration. A tube holder may be included as an accessory device. This is a reusable device intended to be cleaned/disinfected prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06420099001124	GS1