FDA.reportPublic FDA data

SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE

Primary DI
05030267162307
Brand
SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE
Company
Intersurgical Incorporated
Model
2169003
Device description
SMARTCAN™ LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE
Published
2022-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
05030267162307PackageGS16In Commercial Distribution
05030267162291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267162307050302671623075030267162307
05030267162291050302671622915030267162291

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M122000051948502025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT730200151948502025-09-23
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
05030267098088PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 116000011600002025-04-15
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675125525CLIC adapterDrägerwerk AG & Co. KGaABSF2025-04-24
20193489081654MedlineMEDLINE INDUSTRIES, INC.BSF2024-04-24
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
05030267162345SMARTCAN™ SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGEIntersurgical IncorporatedBSF2022-02-01
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
05030267155873ABCAN, LOFLOSORB™ DISPOSABLE CO2 ABSORBER, GREEN TO VIOLET COLOUR CHANGE, 1.1LINTERSURGICAL INCORPORATEDBSF2021-10-28
B005007200AincA®ANESTHESIA ASSOCIATES, INC.BSF2021-03-31
B00500720720AincA®ANESTHESIA ASSOCIATES, INC.BSF2021-03-31
B00500720A0AincA®ANESTHESIA ASSOCIATES, INC.BSF2021-03-31
07325710011577CO2 absorber (disposable), 12 pcs/pkgMaquet Critical Care ABBSF2020-05-26
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00817081026047Column, Sodasorb Disposable, 5.75" LA-M SYSTEMS, LLCBSF2020-03-29
00817081026054Column, Ascarite, Disposable, 3.5 InA-M SYSTEMS, LLCBSF2020-03-29
00817081026061Column, Ascarite, Desiccator, DisposableA-M SYSTEMS, LLCBSF2020-03-29
00817081026078Column, Ascarite, Desiccator, DisposableA-M SYSTEMS, LLCBSF2020-03-29
00817081026085Column, Desiccator, Disposable, 7 InA-M SYSTEMS, LLCBSF2020-03-29
00817081022766ABSORBENT, CO2, CarbolimeA-M SYSTEMS, LLCBSF2019-12-06
00817081022773ABSORBENT, C02, SODALIMEA-M SYSTEMS, LLCBSF2019-12-06