FDA.reportPublic FDA data

"""Y"" Small Bore Infiltration Tubing"

Primary DI
B458246009001
Brand
"""Y"" Small Bore Infiltration Tubing"
Company
The Wells Johnson Company
Model
24600900
Catalog number
24-6009-00
Device description
"""Y"" Small Bore Infiltration Tubing, Dual Spike, Sterile, Single Use"
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B458246009001PrimaryHIBCC0
B458246009000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Regulatory Flags#

DUNS number
048931625
Device count
10
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
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10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
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14026704933119PLEUR-EVACTELEFLEX INCORPORATEDGAZ2024-11-18
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08809083944834EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944841EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944858EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944865EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944872EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944889EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944896EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944902EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944919EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944926EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
20192253051909ArgyleCardinal Health 200, LLCGAZ2024-08-20
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20192253051916ArgyleCardinal Health 200, LLCGAZ2024-07-29
20192253051923ArgyleCardinal Health 200, LLCGAZ2024-07-29