Penlon 53454

GUDID 05051977000260

KEY FILLER ASSEMBLY FOR SEVOFLURANE

PENLON LTD

Sevoflurane anaesthesia vaporizer

• Primary Device ID: 05051977000260
• NIH Device Record Key: 0df05379-02b8-47d6-a0fd-e6d16d3d44a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Penlon
• Version Model Number: 53454
• Catalog Number: 53454
• Company DUNS: 458942687
• Company Name: PENLON LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 800-328-6216
• Email: customer.service@penlon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051977000260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053564

FDA Product Code

• CAD: Vaporizer, Anesthesia, Non-Heated

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: 2016-09-07

On-Brand Devices [Penlon]

• 05051977000536: The Sigma Delta MRI vaporizer is designed for incorporation in the fresh gas supply system of co
• 05051977000444: KEY FILLER ASSEMBLY FOR HALOTHANE
• 05051977000390: THEATRE HIGH SUC FLOOR UNIT C/W 2 V SKT
• 05051977000383: EAST HIGH SUCTION-REMOTE PROBE V PLATE
• 05051977000376: LOW SUCTION - REMOTE PROBE - V PLATE
• 05051977000352: EAST HIGH SUCTION-REMOTE PROBE - V PLATE
• 05051977000345: HIGH VAC SUCTION ASSY 4M HOSE
• 05051977000321: LOW SUCTION - DIRECT PROBE
• 05051977000307: HIGH SUCTION - REMOTE PROBE - RAIL CLAMP 0.5M Hose Length
• 05051977000291: HIGH SUCTION - REMOTE PROBE - RAIL CLAMP
• 05051977000277: LOW SUCTION - REMOTE PROBE - RAIL CLAMP
• 05051977000260: KEY FILLER ASSEMBLY FOR SEVOFLURANE
• 05051977000222: KEY FILLER ASSEMBLY FOR ISOFLURANE
• 05051977000215: EAST HIGH SUCTION-REMOTE - RAIL CLAMP
• 05051977000208: EAST HIGH SUCTION - NO FITTINGS
• 05051977000192: EAST LOW SUCTION - DIRECT PROBE
• 05051977000185: HIGH SUCTION - 1/8" NPT UNIVERSAL THREAD
• 05051977000178: HIGH SUCTION CONTROLLER+DIRECT PROBE
• 05051977000154: HIGH SUCTION - DIRECT PROBE DIN
• 05051977000147: EAST HIGH SUCTION - DIRECT PROBE
• 05051977000130: HIGH SUCTION CONTROLLER
• 05051977000123: EAST LOW SUCTION - NO FITTINGS
• 05051977000116: The Sigma Delta vaporizer is designed for incorporation in the fresh gas supply system of contin
• 05051977000093: A200SP
• 05051977000086: Nuffield 200 MRI
• 05051977000062: Nuffield 200
• 05051977000055: AV-S Remote
• 05051977000048: AV-S Combined
• 05051977000031: Prima 445
• 05051977000024: Prima 440
• 05051977000017: Prima 460
• 05051977000000: Prima 450
• 05051977001595: Quik-Fil drain funnel and key assembly
• 05051977000819: Reusable - ISO ‘Green’ System Diamond Fibrelight Blade
• 05051977000802: Green System standard handle use in MRI environment
• 05051977000796: Reusable - ISO ‘Green’ System MRI Blade (Macintosh, Miller, Robertshaw, Seward, McCoy)
• 05051977000789: Reusable - Premier Fibrelight ISO ‘Red’ Handle (Stubby, Standard, Penlight)
• 05051977000772: Reusable - Premier Conventional Handle (Stubby, Standard, Penlight)
• 05051977000765: Reusable - ISO ‘Red’ System Premier Fibrelight Blade
• 05051977000758: Reusable - Premier Conventional Blade (Seward, Macintosh, Robertshaw, Wisconsin, Miller)
• 05051977000635: Disposable - Laryngoscope Blade (Box of 20)
• 05051977000628: Reusable - Diamond Fibrelight ISO ‘Green’ handle (Stubby, Standard, Penlight)
• 05051977000611: Flexible-end McCoy laryngoscope ISO 'Red' and Conventional Blade, Handle (Seward, MacIntosh)
• 05051977000604: Disposable - Laryngoscope Handle (Box of 20)
• 05051977000598: Reusable - ISO ‘Green’ System Diamond Fibrelight Blade (Seward, Macintosh, Robertshaw, Mille