FDA.reportPublic FDA data

SpiraLith Ca

Primary DI
00860008449832
Brand
SpiraLith Ca
Company
Micropore, Inc.
Model
Rx-3719C
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10860008449839PackageGS16In Commercial Distribution
00860008449832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000844983910860008449839
00860008449832008600084498328600084498320860008449832

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide absorber, single-useA non-sterile, prefilled, sealed container (i.e., a canister with connectors) that constitutes a complete anaesthesia absorber, which is intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled by the manufacturer with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime) to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a single-use device.

Regulatory Flags#

DUNS number
042903703
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008449870SpiraLith CaRx-3616C2025-05-28
10860008449877SpiraLith CaRx-3616C2025-05-28
00860008449825SpiraLith CaRx-2903C2024-05-29
00860008449801SpiraLith CaRx-2903C2024-05-29
10860008449839SpiraLith CaRx-3719C2022-09-23
00860008449849SpiraLith CaRx-3903C2022-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008449870SpiraLith CaMicropore, Inc.CBL2025-05-28
10860008449877SpiraLith CaMicropore, Inc.CBL2025-05-28
10889483583364Medisorb™AirLife Finland OyCBL2025-04-22
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