Penlon

GUDID 05051977000116

The Sigma Delta vaporizer is designed for incorporation in the fresh gas supply system of continuous flow anaesthetic machines, directly connected bet

PENLON LTD

Sevoflurane anaesthesia vaporizer
Primary Device ID05051977000116
NIH Device Record Keyf315934c-ba7d-4668-95df-54d9720d640a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePenlon
Version Model NumberSigma Delta
Company DUNS458942687
Company NamePENLON LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com
Phone800-328-6216
Emailcustomer.service@penlon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105051977000116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CADVaporizer, Anesthesia, Non-Heated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-26

On-Brand Devices [Penlon]

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

Trademark Results [Penlon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PENLON
PENLON
72180925 0776687 Live/Registered
LONGWORTH SCIENTIFIC INSTRUMENT COMPNAYLIMITED
1963-11-12
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