Key Filler Bottle Adaptor MRI

Basic Information

• Brand Name: Key Filler Bottle Adaptor MRI
• Primary DI: 05051977000314
• Version / Model: Key Filler Bottle Adaptor MRI
• Company Name: PENLON LTD
• Labeler DUNS: 458942687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ffde5559-e61d-4b55-ac3c-4a630036ab63

Device Description

Key Filler Bottle Adaptor for use with Isoflurane, Halothane & Sevoflurane in an MRI Environment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
36979	Desflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent desflurane 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	05051977000314	GS1

Premarket Submissions

Submission Number	Supplement Number
K053564	000