FDA.reportPublic FDA data

Penlon

Primary DI
05051977000093
Brand
Penlon
Company
PENLON LTD
Model
A200SP
Published
2016-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BSFAbsorber, Carbon-Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSFAbsorber, Carbon-DioxideAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051977000093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051977000093050519770000935051977000093

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide absorber, reusableA non-sterile, refillable container (e.g., a canister) intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime), directly or via a single-use absorbent cartridge, to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458942687
Device count
1
Premarket exempt
true
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
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
04048675125525CLIC adapterDrägerwerk AG & Co. KGaABSF2025-04-24
10193489081657MedlineMEDLINE INDUSTRIES, INC.BSF2024-04-24
20193489081654MedlineMEDLINE INDUSTRIES, INC.BSF2024-04-24
00850039679063Sodasorb® Molecular Products Inc.BSF2023-09-05
10850039679060Sodasorb® Molecular Products Inc.BSF2023-09-05
00850039679117AriaMolecular Products Inc.BSF2023-09-05
00850039679124AriaMolecular Products Inc.BSF2023-09-05
00850039679131AriaMolecular Products Inc.BSF2023-09-05
00850039679179Sofnolime® Molecular Products Inc.BSF2023-09-05
10850039679022Sodasorb® HMED, 4-8, W-V Indicating, Pre-Paks (12 cts/box)Molecular Products Inc.BSF2022-12-11
00850039679025Sodasorb® HMED, 4-8, W-V Indicating, Individual Pre-PakMolecular Products Inc.BSF2022-12-11
00850039679087Sofnolime® 2550, W-V Indicating, Individual Disposable CartridgesMolecular Products Inc.BSF2022-12-11
05030267162291SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGEIntersurgical IncorporatedBSF2022-02-01
05030267162338SMARTCAN™ SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGEIntersurgical IncorporatedBSF2022-02-01
05030267162307SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGEIntersurgical IncorporatedBSF2022-02-01
05030267162345SMARTCAN™ SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGEIntersurgical IncorporatedBSF2022-02-01
05030267063710DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/VIntersurgical IncorporatedBSF2021-10-28
05030267063741DRUM: 1KG SODA LIME CARTRIDGE LOFLOSORB - G/VIntersurgical IncorporatedBSF2021-10-28
05030267090341IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/VIntersurgical IncorporatedBSF2021-10-28
05030267100187IS CAN: 1KG SODA LIME ABSORBER - LOFLOSORB G/VIntersurgical IncorporatedBSF2021-10-28
05030267117024PYRAMID MKII: SODA LIME ABSORBER SHERASORB W/VIntersurgical IncorporatedBSF2021-10-28
05030267117062PYRAMID MKII LOFLOSORB G/VIntersurgical IncorporatedBSF2021-10-28
05030267155798ABCAN, SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE, 1.1LIntersurgical IncorporatedBSF2021-10-28
05030267155866ABCAN, LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE, 1.1LIntersurgical IncorporatedBSF2021-10-28
05030267047086DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/VINTERSURGICAL INCORPORATEDBSF2021-10-28
05030267044382DRUM: 1KG SODA LIME CARTRIDGE LOFLOSORB - G/VINTERSURGICAL INCORPORATEDBSF2021-10-28
05030267090358IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/VINTERSURGICAL INCORPORATEDBSF2021-10-28
05030267090273IS CAN: 1KG SODA LIME ABSORBER - LOFLOSORB G/VINTERSURGICAL INCORPORATEDBSF2021-10-28
05030267117031PYRAMID MKII: SODA LIME ABSORBER SHERASORB W/VINTERSURGICAL INCORPORATEDBSF2021-10-28
05030267117079PYRAMID MKII LOFLOSORB G/VINTERSURGICAL INCORPORATEDBSF2021-10-28