FDA.reportPublic FDA data

Penlon

Primary DI
05051977002011
Brand
Penlon
Company
PENLON LTD
Model
Sigma Delta Vaporizer / Isoflurane
Catalog number
410502I
Device description
Sigma Delta Vaporizer / Isoflurane
Published
2024-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CADVaporizer, Anesthesia, Non-Heated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CADVaporizer, Anesthesia, Non-HeatedAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002343000SIGMA DELTAPenlon , Ltd.2001-06-08CAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051977002011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051977002011050519770020115051977002011

GMDN Terms#

Term, Definition table
TermDefinition
Isoflurane anaesthesia vaporizerA device used to vaporize the anaesthetic agent isoflurane 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-328-6216customer.service@penlon.com

Regulatory Flags#

DUNS number
458942687
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051977003223Penlon4080010044080010042025-04-10
05051977003766Penlon4080010044080010042024-12-06
05051977000857PenlonPrima 460 Anaesthetic Machine50113052024-12-06
05051977001465PenlonSigma Delta Vaporizer / Halothane410502H2024-12-06
05051977002028PenlonSigma Delta Vaporizer / Sevoflurane410502S2024-12-06
05051977002035PenlonSigma Delta MRI Vaporizer / Sevoflurane410502S-M2024-12-06
05051977002042PenlonSigma Delta MRI Vaporizer / Isoflurane410502I-M2024-12-06
05051977003599Penlon4080010014080010012024-12-06
05051977003605Penlon4080010024080010022024-12-06
05051977003612Penlon4080010054080010052024-12-06
05051977003629Penlon4080010064080010062024-12-06
05051977003636Penlon4080010074080010072024-12-06
05051977003643Penlon4080010084080010082024-12-06
05051977003650Penlon4080010094080010092024-12-06
05051977003667Penlon4080010104080010102024-12-06
05051977003674Penlon4080010114080010112024-12-06
05051977003681Penlon4080010124080010122024-12-06
05051977003698Penlon4080010134080010132024-12-06
05051977003704Penlon4080010144080010142024-12-06
05051977003711Penlon4080010154080010152024-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06903053055000V80 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CAD2026-01-08
05051977001465PenlonPENLON LTDCAD2024-12-06
05051977002028PenlonPENLON LTDCAD2024-12-06
05051977002035PenlonPENLON LTDCAD2024-12-06
05051977002042PenlonPENLON LTDCAD2024-12-06
05051977001595PenlonPENLON LTDCAD2023-06-21
B005003320AincA®ANESTHESIA ASSOCIATES, INC.CAD2021-03-31
00840682124720TECDATEX-OHMEDA INCCAD2018-03-12
00840682124737TECDATEX-OHMEDA INCCAD2018-03-12
00840682124744TECDATEX-OHMEDA INCCAD2018-03-12
00840682124751TECDATEX-OHMEDA INCCAD2018-03-12
10620974002038Quik FilSouthmedic IncorporatedCAD2018-02-23
05051977000314Key Filler Bottle Adaptor MRIPENLON LTDCAD2017-08-01
05051977000536PenlonPENLON LTDCAD2017-07-18
05051977000444PenlonPENLON LTDCAD2017-02-14
10841522118135Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118173Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118258Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118265Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118326Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118357Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118371Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118401Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522119323Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106712Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118234Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106774Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106736Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106750Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106798Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03