FDA.reportPublic FDA data

Jac-cell USA Inc.

Primary DI
B461JAU117013
Brand
Jac-cell USA Inc.
Company
JAC CELL USA INC
Model
JAU-1170
Device description
INFILTRATION TUBING FOR PERISTALTIC PUMP WITH 2 SPIKES
Published
2017-03-30
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
B461JAU117013PrimaryHIBCC0
B461JAU117002Unit 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
B461JAU11681Jac-cell USA Inc.JAU-11682017-02-27
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

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