FDA.reportPublic FDA data

AMSORB® PLUS

Primary DI
05060505643701
Brand
AMSORB® PLUS
Company
ARMSTRONG MEDICAL LTD
Model
AMAB3801GE
Device description
AMAB3801GE 2105489-003 AMSORB PLUS PREFILLED G-CAN 1.0L
Published
2021-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
05060505643701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060505643701050605056437015060505643701

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
239659915
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05059443003579THERMAWRAP ADULT HEAD COVERAMTW10002023-05-23
05060505643718AMSORB® PLUSAMAB3201GE2021-08-18
05060505643725AMSORB® PLUSAMAB3803GE2021-08-18
15059443000001AMSORB® PLUSAMAB30002021-08-18
15059443000018AMSORB® PLUSAMAB32002021-08-18
15059443000025AMSORB® PLUSAMAB32012021-08-18
15059443000032AMSORB® PLUSAMAB34002021-08-18
15059443000049AMSORB® PLUSAMAB38002021-08-18
15059443000056AMSORB® PLUSAMAB38012021-08-18
15059443000070AMSORB® PLUSAMAB38032021-08-18
15059443000087AMSORB® PLUSAMAB40012021-08-18
15059443014466AMSORB® PLUSAMAB4001GE2021-08-18
05060505643732AMSORB® PLUSAMAB3000GE2021-08-17

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Primary DI, Brand, Company table
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20889483590529Medisorb™AirLife Finland OyCBL2025-04-22
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20889483577414Medisorb™AirLife Finland OyCBL2025-04-09
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07898592088819AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
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07898592088888AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
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07898592088956AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
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