FDA.reportPublic FDA data

PC

Primary DI
40026072025329
Brand
PC
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
55-01-0027
Device description
CARBOLIME,GEMULTISTYLE,6/CS
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
40026072025329PackageGS16In Commercial Distribution
00026072025321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202532940026072025329
00026072025321000260720253210260720253210026072025321

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099674145
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
true
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
00026072017999PC15008-03P2023-12-22
00026072018002PC15008-03P-A2023-12-22
00026072018019PC15008-03T2023-12-22
00026072018026PC15008-03T-A2023-12-22
00026072018033PC15008-03TP22023-12-22
00026072018040PC15008-03TP2-A2023-12-22
00026072018057PC15008-03Y2023-12-22
00026072018064PC15008-03Y-A2023-12-22
00026072018071PC15008-03YP12023-12-22
00026072018088PC15008-03YP1-A2023-12-22
00026072018095PC15008-03YP22023-12-22
00026072018101PC15008-03YP2-A2023-12-22
00026072018118PC15008-132023-12-22
00026072018125PC15008-13-A2023-12-22
00026072018132PC15008-13P2023-12-22
00026072018149PC15008-13P-A2023-12-22
00026072018156PC15008-13T2023-12-22
00026072018163PC15008-13YP2-A2023-12-22
00026072018170PC15009-032023-12-22
00026072018187PC15009-03-A2023-12-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20889483577421Medisorb™AirLife Finland OyCBL2025-04-09
10889483573488Medisorb™AirLife Finland OyCBL2025-04-07
20889483603465Medisorb™AirLife Finland OyCBL2025-04-01
20889483603472Medisorb™AirLife Finland OyCBL2025-04-01
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
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