FDA.reportPublic FDA data

Medisorb™

Primary DI
20889483583361
Brand
Medisorb™
Company
AirLife Finland Oy
Model
427000100
Catalog number
427000100
Device description
Medisorb™ Pre-Packed Rounds, Disposable
Published
2025-04-22
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
CBLAbsorbent, Carbon-Dioxide

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483583361PackageGS112In Commercial Distribution
10889483583364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948358336120889483583361
1088948358336410889483583364

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide absorbent cartridgeA non-sterile, prefilled, sealed container (cartridge or drum) containing a carbon dioxide absorbent material (e.g., granules of treated soda lime) intended to be inserted into a reusable anaesthesia system absorber for the removal of carbon dioxide (CO2) exhaled by a patient into an anaesthesia unit/workstation breathing circuit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
368457563
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752140912Vital Signs™M1031274M10312742021-01-28
10190752145641Vital Signs™M1031273M10312732021-07-06
10190752191235Vital Signs™M1031274M10312742023-05-30
10190752125582Vital Signs™2025248-0012025248-0012018-11-23
10190752125599Vital Signs™2025248-0022025248-0022018-11-23
10190752125629Vital Signs™9446-9119446-9112018-11-23
10190752125636Vital Signs™9446-9139446-9132018-11-23
10190752181380Vital Signs™9446-9119446-9112020-12-15
10190752181397Vital Signs™9446-9139446-9132020-12-15
10190752179349Vital Signs™2025248-0012025248-0012020-12-01
10190752179356Vital Signs™2025248-0022025248-0022020-12-01
10889483587881AirLife™6600-0196-7006600-0196-7002025-03-26
10889483587904AirLife™6600-0208-7006600-0208-7002025-03-26
10889483590003AirLife™800423180042312025-04-02
10889483590584AirLife™857020385702032025-04-02
10889483601563AirLife™M1010534M10105342025-04-02
10889483602522AirLife™M1038637M10386372025-03-31
10889483603222Vital Signs™M1138830M11388302025-04-02
10889483586549AirLife™5570195005570195002025-04-02
10889483586624AirLife™5570701005570701002025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008449870SpiraLith CaMicropore, Inc.CBL2025-05-28
10860008449877SpiraLith CaMicropore, Inc.CBL2025-05-28
10889483583364Medisorb™AirLife Finland OyCBL2025-04-22
10889483589922Medisorb™AirLife Finland OyCBL2025-04-22
10889483590522Medisorb™AirLife Finland OyCBL2025-04-22
20889483589929Medisorb™AirLife Finland OyCBL2025-04-22
20889483590529Medisorb™AirLife Finland OyCBL2025-04-22
10889483577417Medisorb™AirLife Finland OyCBL2025-04-09
10889483577424Medisorb™AirLife Finland OyCBL2025-04-09
20889483577414Medisorb™AirLife Finland OyCBL2025-04-09
20889483577421Medisorb™AirLife Finland OyCBL2025-04-09
10889483573488Medisorb™AirLife Finland OyCBL2025-04-07
10889483603468Medisorb™AirLife Finland OyCBL2025-04-01
10889483603475Medisorb™AirLife Finland OyCBL2025-04-01
20889483603465Medisorb™AirLife Finland OyCBL2025-04-01
20889483603472Medisorb™AirLife Finland OyCBL2025-04-01
10193489081633MEDLINEMEDLINE INDUSTRIES, INC.CBL2024-10-25
20193489081630MEDLINEMEDLINE INDUSTRIES, INC.CBL2024-10-25
00850022357817Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357824Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357831Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357848Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
07898592088819AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088833AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088888AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088901AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088956AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088970AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592089021AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26