FDA.reportPublic FDA data

PC

Primary DI
00026072025277
Brand
PC
Company
Allied Medical, LLC
Model
55-01-0018
Device description
LITHOLYME,GECOMPACTSTYLE,10/CS
Published
2023-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
40026072025275PackageGS110In Commercial Distribution
00026072025277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202527540026072025275
00026072025277000260720252770260720252770026072025277

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.

Regulatory Flags#

DUNS number
119066872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10860008449877SpiraLith CaMicropore, Inc.CBL2025-05-28
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10889483589922Medisorb™AirLife Finland OyCBL2025-04-22
10889483590522Medisorb™AirLife Finland OyCBL2025-04-22
20889483583361Medisorb™AirLife Finland OyCBL2025-04-22
20889483589929Medisorb™AirLife Finland OyCBL2025-04-22
20889483590529Medisorb™AirLife Finland OyCBL2025-04-22
10889483577417Medisorb™AirLife Finland OyCBL2025-04-09
10889483577424Medisorb™AirLife Finland OyCBL2025-04-09
20889483577414Medisorb™AirLife Finland OyCBL2025-04-09
20889483577421Medisorb™AirLife Finland OyCBL2025-04-09
10889483573488Medisorb™AirLife Finland OyCBL2025-04-07
10889483603468Medisorb™AirLife Finland OyCBL2025-04-01
10889483603475Medisorb™AirLife Finland OyCBL2025-04-01
20889483603465Medisorb™AirLife Finland OyCBL2025-04-01
20889483603472Medisorb™AirLife Finland OyCBL2025-04-01
10193489081633MEDLINEMEDLINE INDUSTRIES, INC.CBL2024-10-25
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
00850022357848Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
00850022357855Xenon MasterMedi/Nuclear Corporation, Inc.CBL2024-09-10
07898592088819AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088833AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088888AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088901AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088956AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26
07898592088970AtrasorbATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES LTDACBL2024-07-26