FDA.reportPublic FDA data

PYRAMID MKII LOFLOSORB G/V

Primary DI
05030267117062
Brand
PYRAMID MKII LOFLOSORB G/V
Company
Intersurgical Incorporated
Model
2193001
Device description
PYRAMID MKII LOFLOSORB G/V
Published
2021-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
05030267117079PackageGS16In Commercial Distribution
05030267117062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267117079050302671170795030267117079
05030267117062050302671170625030267117062

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide absorbentAn absorbent material (e.g., granules of treated soda lime) intended to be placed into a reusable carbon dioxide absorber to remove carbon dioxide (CO2) from the exhaled gases in a patient breathing circuit by chemical reaction. It is typically available in large plastic containers [e.g., 5 kilogrammes (Kg) by weight] and poured into clean, reusable absorbers. The absorbent is typically manufactured to change colour during its use (e.g., from white to violet, pink to white, or green to violet) to indicate need for replacement. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15M15111112026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15M15121112026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22F15131112026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22F15141112026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22F15151112026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22F15161112026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22F15171112026-06-10
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)82010302026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)82020302026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)82030302026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)82040302026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)82050302026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)82150302026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)82250302026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)89030302026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)89040302026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)89050302026-06-02
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE1997000S2026-04-28
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430352026-04-21
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY11410352026-04-21

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
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
05030267155804ABCAN, SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE, 1.1LINTERSURGICAL INCORPORATEDBSF2021-10-28