Penlon

Basic Information

• Brand Name: Penlon
• Primary DI: 05051977002035
• Version / Model: Sigma Delta MRI Vaporizer / Sevoflurane
• Catalog Number: 410502S-M
• Company Name: PENLON LTD
• Labeler DUNS: 458942687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-06
• Public Version: 1
• Public Version Date: 2024-12-16
• Public Version Status: New
• Public Device Record Key: 0408aca1-5ad4-4d20-b346-bddcc3f22c4d

Device Description

Sigma Delta MRI Vaporizer / Sevoflurane

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: MR Safe
• 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
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	05051977002035	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002343	000