FDA.reportPublic FDA data

High Volume Harvesting Canister

Primary DI
B458205175000
Brand
High Volume Harvesting Canister
Company
The Wells Johnson Company
Model
3000ml (3L)
Catalog number
20-5175-00
Device description
Wells Johnson High Volume Collection and Harvesting Canister, 3000ml (3L)
Published
2023-07-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
B458205175000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
048931625
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
B458201046020KHOURI CANNULA SET2010460220-1046-022024-01-23

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