FDA.reportPublic FDA data

Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg), Smiths Medical 008880

Primary DI
00850017239043
Brand
Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg), Smiths Medical 008880
Company
Molecular Products US Holdings, Inc.
Model
CD02-0007
Device description
Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg), Smiths Medical 008880
Published
2021-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850017239043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017239043008500172390438500172390430850017239043

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
10850017239156Sodasorb® 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
10850017239194Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak, Smiths Medical 008CD02-00062021-11-17

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