FDA.reportPublic FDA data

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

Primary DI
00810988021269
Brand
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
Company
JET MEDICAL, INC.
Model
JT140184500
Device description
"0.018"" (0.47MM) X 45CM NITINOL GUIDEWIRE"
Published
2018-04-13
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810988021264PackageGS110Not in Commercial Distribution
00810988021269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081098802126450810988021264
00810988021269008109880212698109880212690810988021269

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079506014
Device count
1
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
0081098802096512F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314015012017-06-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
30193489067044NAMICMEDLINE INDUSTRIES, INC.DQX2021-06-03
07613327508499Synchro SELECTStryker CorporationDQX2020-10-20
07613327508512Synchro SELECTStryker CorporationDQX2020-10-20
07613327508529Synchro SELECTStryker CorporationDQX2020-10-20
07613327508581Synchro SELECTStryker CorporationDQX2020-10-20
07613327508628Synchro SELECTStryker CorporationDQX2020-10-20
07613327508635Synchro SELECTStryker CorporationDQX2020-10-20
07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459647Synchro2Stryker CorporationDQX2019-06-20
07613327459661Synchro2Stryker CorporationDQX2019-06-20
08498840011874VYGONVygon CorporationDQX2019-04-08
08498840011881VYGONVygon CorporationDQX2019-04-08
08498840011898VYGONVygon CorporationDQX2019-04-08
08498840011911VYGONVygon CorporationDQX2019-04-08