FDA.reportPublic FDA data

Jac-cell Medic Inc.

Primary DI
B460JA11591
Brand
Jac-cell Medic Inc.
Company
9001-2030 Québec Inc
Model
JA-1159
Device description
Aspiration tubing
Published
2016-12-22
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
B460JA11591PrimaryHIBCC0
B460JA11590Unit 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
253086045
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
B460JA11601Jac-cell Medic Inc.JA-11602016-12-22
B460JA11681Jac-cell Medic Inc.JA-11682016-12-22
B460JA15201Jac-cell MedicJA-15202017-06-28
B460ATI014A0Jac-cell MedicATI-014A2017-04-03
B460ATI0210Jac-cell MedicATI-0212017-04-03

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