AV-S MRI Ventilator

GUDID 05051977000567

AV-S Ventilator for use in an MRI environment

PENLON LTD

Anaesthesia ventilator

• Primary Device ID: 05051977000567
• NIH Device Record Key: 81b6964f-5d85-4b94-93fe-9bf3135279a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AV-S MRI Ventilator
• Version Model Number: AV-S MRI
• Company DUNS: 458942687
• Company Name: PENLON LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051977000567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051222

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-01

Devices Manufactured by PENLON LTD

• 05051977000598 - Penlon: 2023-06-29 Reusable - ISO ‘Green’ System Diamond Fibrelight Blade (Seward, Macintosh, Robertshaw, Miller)
• 05051977000604 - Penlon: 2023-06-29 Disposable - Laryngoscope Handle (Box of 20)
• 05051977000611 - Penlon: 2023-06-29 Flexible-end McCoy laryngoscope ISO 'Red' and Conventional Blade, Handle (Seward, MacIntosh)
• 05051977000628 - Penlon: 2023-06-29 Reusable - Diamond Fibrelight ISO ‘Green’ handle (Stubby, Standard, Penlight)
• 05051977000635 - Penlon: 2023-06-29 Disposable - Laryngoscope Blade (Box of 20)
• 05051977000758 - Penlon: 2023-06-29 Reusable - Premier Conventional Blade (Seward, Macintosh, Robertshaw, Wisconsin, Miller)
• 05051977000765 - Penlon: 2023-06-29 Reusable - ISO ‘Red’ System Premier Fibrelight Blade
• 05051977000772 - Penlon: 2023-06-29 Reusable - Premier Conventional Handle (Stubby, Standard, Penlight)