FDA.reportPublic FDA data

Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak

Primary DI
10850017239156
Brand
Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak
Company
Molecular Products US Holdings, Inc.
Model
CD02-0001
Device description
Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak
Published
2021-11-30
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

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
10850017239156PackageGS112In Commercial Distribution
00850017239159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001723915610850017239156
00850017239159008500172391598500172391590850017239159

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117988954
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850017239159Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister PakCD02-00012021-11-30
00850017239197Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak, Smiths Medical 008CD02-00062021-11-17
00850017239012Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg)CD02-00042021-11-17
00850017239043Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg), Smiths Medical 008880CD02-00072021-11-17
10850017239194Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak, Smiths Medical 008CD02-00062021-11-17

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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
20889483577421Medisorb™AirLife Finland OyCBL2025-04-09
10889483573488Medisorb™AirLife Finland OyCBL2025-04-07
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07898592088956AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
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