FDA.reportPublic FDA data

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

Primary DI
00850039679070
Brand
Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak, U-RAE
Company
Molecular Products Inc.
Model
CD02-0033
Device description
Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak, U-RAE
Published
2022-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850039679070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039679070008500396790708500396790700850039679070

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

Regulatory Flags#

DUNS number
138634006
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
00850039679063Sodasorb® CD02-00142023-09-05
00850039679049Sodasorb® CD02-00132023-09-05
10850039679060Sodasorb® CD02-00142023-09-05
00850039679117AriaPC02-00042023-09-05
00850039679124AriaPC02-00052023-09-05
00850039679131AriaPC02-00062023-09-05
00850039679148Sodasorb® CD02-00512023-09-05
00850039679155Sodasorb® CD02-00522023-09-05
00850039679162Sofnolime® CD02-00532023-09-05
00850039679179Sofnolime® CD02-00552023-09-05
00850039679186Sofnolime® CD02-00542023-09-05
00850039679193Sofnolime® CD02-00572023-09-05
00850039679209Sofnolime® CD02-00582023-09-05
00850039679216Sofnolime® CD02-00562023-09-05
00850039679223Sodasorb® CD02-00592023-09-05
10850039679008Sodasorb® HMED, 4-8, W-V Indicating, Canister Pak (12 bags/box)CD02-00012022-12-11
10850039679022Sodasorb® HMED, 4-8, W-V Indicating, Pre-Paks (12 cts/box)CD02-00052022-12-11
10850039679077Sodasorb® HMED, 4-8, W-V Indicating, Canister Pak (12 bags/box), U-RAECD02-00332022-12-11
10850039679091Sofnolime®, 2550, W-V Indicating, Medical Grade, Canister Pak (12 bags/box)CD02-00492022-12-11
00850039679001Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister PakCD02-00012022-12-11

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