FDA.reportPublic FDA data

12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)

Primary DI
00810988020965
Brand
12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)
Company
JET MEDICAL, INC.
Model
JT031401501
Device description
14F X 15CM JET FLOW ST KIT
Published
2017-06-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPBCatheter, Hemodialysis, Non-Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810988020960PackageGS110Not in Commercial Distribution
00810988020965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081098802096050810988020960
00810988020965008109880209658109880209650810988020965

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableAn implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.

Contacts#

Phone, Email table
PhoneEmail
+1(866)385-4047customerservice@jetmedicalinc.com

Regulatory Flags#

DUNS number
079506014
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081098802095812F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314012012017-06-20
0081098802098912F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314024012017-06-20
0081098802097212 F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314020012017-06-20
0081098802000215.5F X 24CM JET FLOW LT CATHETERJT011552401JT0115524012015-07-20
0081098802001915.5F X 28CM JET FLOW LT CATHETERJT011552801JT0115528012015-07-20
0081098802002615.5F X 32CM JET FLOW LT CATHETERJT011553201JT0115532012015-07-20
0081098802003315.5F X 36CM JET FLOW LT CATHETERJT011553601JT0115536012015-07-20
0081098802004015.5F X 55CM JET FLOW LT CATHETERJT011555501JT0115555012015-07-20
0081098802005715.5F X 24CM JET FLOW PRE-CURVED LT CATHETERJT021552401JT0215524012015-08-25
0081098802006415.5F X 28CM JET FLOW PRE-CURVED LT CATHETERJT021552801JT0215528012015-07-20
0081098802007115.5F X 32CM JET FLOW PRE-CURVED LT CATHETERJT021553201JT0215532012015-08-25
0081098802008815.5F X 36CM JET FLOW PRE-CURVED LT CATHETERJT021553601JT0215536012015-07-20
008109880205833F X 55CM SINGLE LUMEN POWER PICCJT05035501JT050355012015-07-20
008109880205904F X 55CM SINGLE LUMEN POWER PICCJT05045501JT050455012015-07-20
008109880206065F X 55CM DOUBLE LUMEN POWER PICCJT06055501JT060555012015-07-20
008109880206514F STIFF COAXIAL DILATORJT120400000JT1204000002015-07-20
008109880206685F STIFF COAXIAL DILATORJT120500000JT1205000002015-07-20
008109880206824F REGULAR COAXIAL DILATORJT130400000JT1304000002015-07-20
008109880206995F REGULAR COAXIAL DILATORJT130500000JT1305000002015-07-20
008109880208974F X 20CM SINGLE LUMEN MIDLINE CATHETERJT05042000JT050420002015-07-20

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