Penlon

Basic Information

• Brand Name: Penlon
• Primary DI: 05051977000536
• Version / Model: Sigma Delta MRI
• Company Name: PENLON LTD
• Labeler DUNS: 458942687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-18
• Public Version: 4
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: a9b3076b-7a94-4a92-8f93-f925adaf6451

Device Description

Anaesthetic vaporizer use in the MRI environment.

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	868.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36316	Enflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent enflurane (Ethrane) and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	No	Active
36891	Halothane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent halothane (also known as fluorothane) and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	No	Active
36890	Isoflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent isoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	No	Active
36980	Sevoflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent sevoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051977000536	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002343	000