FDA.reportPublic FDA data

"Y" Small Bore Infiltration Tubing

Primary DI
B458246009000
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048931625
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B458201826020TABLE, VTS, 240VAC2018260220-1826-022025-09-08
B458201550000C-MAX2015500020-1550-002025-09-05
B458201314000DEL VECCHIO 12-HOLE, 4MM, 1" BLUE ERGO2013140020-1314-002025-07-28
B458205186000Small Volume Harvesting Canister250ml20-5186-002025-02-05
B458205187000Small Volume Harvesting Canister500ml20-5187-002025-02-05
B458208300000HVC3™ 2083000020-8300-002024-10-08
B458201266000FISCHER (ALOUF)2012660020-1266-002024-04-19
B458201360000INFILTRATION CANNULA SET, WIS (2)2013600020-1360-002024-02-23
B458201046020KHOURI CANNULA SET2010460220-1046-022024-01-23
B458201281000KHOURI HARVESTING 12g2012810020-1281-002024-01-23
B458201284000KHOURI SPATULA 14g x 15cm2012840020-1284-002024-01-23
B458201235000CUSTOM CANNULA2012350020-1235-002023-11-27
B458205061000Wells Johnson Elite Infiltrator/Aspirator2050610020-5061-002023-11-20
B458205066000Wells Johnson Elite Infiltrator/Aspirator2050660020-5066-002023-11-20
B458201825000TABLE, VTS, 120VAC2018250020-1825-002023-08-31
B458201826000TABLE, VTS, 240VAC2018260020-1826-002023-08-31
B458201260000GANDHI DISRUPTOR2012600020-1260-002023-08-24
B458205158000SORENSON LINER 1900cc2051580020-5158-002023-07-24
B458205153000BAXTER CANISTER 1500cc2051530020-5153-002023-07-21
B458205154000BAXTER THIN WALL LINER 1500cc2051540020-5154-002023-07-21

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