FDA.reportPublic FDA data

Jac-cell USA Inc.

Primary DI
B461JAU11681
Brand
Jac-cell USA Inc.
Company
JAC CELL USA INC
Model
JAU-1168
Device description
Infiltration tubing for peristaltic pumps
Published
2017-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B461JAU11681PrimaryHIBCC0
B461JAU116809Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum tubing, single-useA sterile, flexible, cylindrical device used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of a malleable plastic or silicone material and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required, e.g., for an autologous blood transfusion system. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015023538
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B461JAU97971Jac-cell USA Inc.JAU-97972017-06-28
B461JAU11591Jac-cell USA In.cJAU-11592017-02-27
B461JAU116012Jac-cell USA IncJAU-11602017-02-27
B461JAU117013Jac-cell USA Inc.JAU-11702017-03-30
B461JAU142000Jac-cell USAJAU-14202018-08-30
B461JAU142011Jac-cell USAJAU-14202018-08-30
B461JAU142213Jac-cell USA Inc.JAU-14222017-02-15
B461JAU15201Jac-cell USA Inc.JAU-15202017-06-28
B461JAU3092R0Jac-cell USA Inc.JAU-3092-R2017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDBYY2026-06-10
05060212054630Silicone Tube 0.3mm ID x 0.64mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054654Silicone DCR Tube 1.02mm ID x 2.16mm OD x 40mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054661Silicone Tube 1.02mm ID x 2.16mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054678Silicone Tube 1.02mm ID x 2.16mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054685Silicone Tube 1.57mm ID x 3.18mm OD x 250mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054692Silicone Tube 1.57mm ID x 3.18mm OD x 250mm long, two piecesDTR MEDICAL LIMITEDBYY2026-06-10
05060212054715Silicone Tube 1.57mm ID x 3.18mm OD x 450mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054722Silicone Tube 1.57mm ID x 3.18mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054753Silicone Tube 1.98mm ID x 3.18mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054791Silicone Tube 2.65mm ID x 4.88mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054814Silicone Tube 3.2mm ID x 6.4mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054838Silicone Tube 3.2mm ID x 6.4mm OD x 800mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054845Silicone Tube 3.2mm ID x 6.4mm OD 1100mm long- HouseDTR MEDICAL LIMITEDBYY2026-06-10
05060212054876Silicone Tube 4.8mm ID x 7.9mm OD x 150mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054883Silicone Tube 4.8mm ID x 7.9mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054890Silicone Tube 4.8mm ID x 7.9mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054913Silicone Tube 4.8mm ID x 7.9mm OD x 760mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054944Silicone Tube 4.8mm ID x 7.9mm OD x 1350mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054951Silicone Tube 4.8mm ID x 7.9mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054968Silicone Tube 4.8mm ID x 7.9mm OD x 1750mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055002Silicone Tube 5.0mm ID x 8.3mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055026Silicone Tube 5.0mm ID x 8.3mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055095Silicone Tube 6.4mm ID x 9.5mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055118Silicone Tube 6.4mm ID x 9.5mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055125Silicone Tube 6.4mm ID x 9.5mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411983229Sterile Silicone Tube 1.57 ID x 2.41 OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411984066Silicone Tube 3.2mm ID x 6.4mm OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
00199150028399Liberant™EV3, INCBYY2026-05-07
10192253042894ArgyleCardinal Health 200, LLCBYY2025-02-27