FDA.reportPublic FDA data

SORENSON LINER 1900cc

Primary DI
B458205158001
Brand
SORENSON LINER 1900cc
Company
The Wells Johnson Company
Model
20515800
Catalog number
20-5158-00
Device description
Disposable, Sorenson Liner 1900cc, 10/case, for use with Sorenson Canister 1900cc (P/N: 20-5157-00)
Published
2023-07-24
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
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B458205158001PrimaryHIBCC0
B458205158000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suction system canister linerA device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.

Regulatory Flags#

DUNS number
048931625
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B458205997000HVP Cart2059970020-5997-002026-04-20
B458205998000Wells Johnson Hymen Cart2059980020-5998-002026-04-20
B458205061000Wells Johnson Elite Infiltrator/Aspirator2050610020-5061-002023-11-20
B458205066000Wells Johnson Elite Infiltrator/Aspirator2050660020-5066-002023-11-20
B458201300000DEL VECCHIO RE-INJECTION, 14g2013000020-1300-002025-09-10
B458201826020TABLE, VTS, 240VAC2018260220-1826-022025-09-08
B458201550000C-MAX2015500020-1550-002025-09-05
B458201826000TABLE, VTS, 240VAC2018260020-1826-002023-08-31
B4582013390003-PORT RADIAL VT2013390020-1339-002023-07-19
B458201314000"DEL VECCHIO 12-HOLE, 4MM, 1"" BLUE ERGO"2013140020-1314-002025-07-28
B458208300000HVC3™ 2083000020-8300-002024-10-08
B458205186000Small Volume Harvesting Canister250ml20-5186-002025-02-05
B458205187000Small Volume Harvesting Canister500ml20-5187-002025-02-05
B458205173000High Volume Harvesting Canister1000ml (1L)20-5173-002023-07-14
B458205174000High Volume Harvesting Canister2000ml (2L)20-5174-002023-07-14
B458205175000High Volume Harvesting Canister3000ml (3L)20-5175-002023-07-14
B458205188000High Volume Harvesting Canister5000ml (5L)20-5188-002023-07-14
B458201825000TABLE, VTS, 120VAC2018250020-1825-002023-08-31
B458201266000FISCHER (ALOUF)2012660020-1266-002024-04-19
B458201360000INFILTRATION CANNULA SET, WIS (2)2013600020-1360-002024-02-23

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