FDA.report

Jac-cell Medic Inc.

Primary DI
B460JA11681
Brand
Jac-cell Medic Inc.
Company
9001-2030 Québec Inc
Model
JA-1168
Device description
Infiltration tubing for peristaltic pumps
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications

CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B460JA11681PrimaryHIBCC0
B460JA11680Unit of UseHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
253086045
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
true
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 DIBrandModelCatalogPublished
B460JA15201Jac-cell MedicJA-15202017-06-28
B460ATI014A0Jac-cell MedicATI-014A2017-04-03
B460ATI0210Jac-cell MedicATI-0212017-04-03
B460JA11591Jac-cell Medic Inc.JA-11592016-12-22
B460JA11601Jac-cell Medic Inc.JA-11602016-12-22

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