FDA.reportPublic FDA data

TYSHAK II®

Primary DI
04046964339295
Brand
TYSHAK II®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
611934
Catalog number
611934
Device description
PDC534 20MM X 6CM BALL CATH TYSHA II STD
Published
2016-08-09
Public version status
Update
Distribution status
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
DQYCATHETER, PERCUTANEOUS
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003052000
K931009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003052000NUMED TYSHAK II AND Z-MED II PTV CATHETERSNuMED, Inc.2000-11-01LIT
K931009000TYSHAK PERIPHERAL BALLOON DILATION CATHETERNuMED, Inc.1993-12-21LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964339295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964339295040469643392954046964339295

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store at room temp

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
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
04046955642489Seamless™6147026147022023-06-29
04046955668823COMPASS ™6139446139442021-12-07
04046955668847COMPASS ™6139456139452021-12-07
04046955668861COMPASS ™6139466139462021-12-07
04046955668885COMPASS ™6139476139472021-12-07
04046955668908COMPASS ™6139486139482021-12-07
04046955668922COMPASS ™6139496139492021-12-07
04046955668946COMPASS ™6139506139502021-12-07
04046955668960COMPASS ™6139516139512021-12-07
04046955668984COMPASS ™6139526139522021-12-07
04046955669004COMPASS ™6139536139532021-12-07
04046955669028COMPASS ™6139546139542021-12-07
04046955669042COMPASS ™6139556139552021-12-07
04046955669066COMPASS ™6139566139562021-12-07
04046955669080COMPASS ™6139576139572021-12-07
04046955669103COMPASS ™6139586139582021-12-07
04046955669127COMPASS ™6139596139592021-12-07
04046955669141COMPASS ™6139606139602021-12-07
04046955669165COMPASS ™6139616139612021-12-07
04046955669189COMPASS ™6139626139622021-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.DQY2026-10-29
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
08718122024218Climber Guiding CatheterPendraCare International B.V.DQY2026-05-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00884450838167Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
00884450838174Ventrax™Merit Medical Systems, Inc.DQY2026-01-13