FDA.reportPublic FDA data

Key Filler Bottle Adaptor MRI

Primary DI
05051977000314
Brand
Key Filler Bottle Adaptor MRI
Company
PENLON LTD
Model
Key Filler Bottle Adaptor MRI
Device description
Key Filler Bottle Adaptor for use with Isoflurane, Halothane & Sevoflurane in an MRI Environment
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
K053564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053564000KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454Penlon Limited2006-03-03CAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051977000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051977000314050519770003145051977000314

GMDN Terms#

Term, Definition table
TermDefinition
Desflurane anaesthesia vaporizerA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458942687
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
05051977002011PenlonSigma Delta Vaporizer / Isoflurane410502I2024-12-06
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

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
05051977002011PenlonPENLON 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
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