DxTerity™ TRA Angio-Kit

GUDID 20643169738373

CATH AKUNIV603 DXT 6F 5PK ANGIO RAD KIT

MEDTRONIC, INC.

Angiographic catheter, single-use
Primary Device ID20643169738373
NIH Device Record Key48c0a1ab-d533-4930-ba76-252c2ba6cdda
Commercial Distribution StatusIn Commercial Distribution
Brand NameDxTerity™ TRA Angio-Kit
Version Model NumberAKUNIV603
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light
Special Storage Condition, SpecifyBetween 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169738379 [Primary]
GS120643169738373 [Package]
Contains: 00643169738379
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-30

On-Brand Devices [DxTerity™ TRA Angio-Kit]

20643169738380CATH AKUNIV604 DXT 6F 5PK ANGIO RAD KIT
20643169738373CATH AKUNIV603 DXT 6F 5PK ANGIO RAD KIT
20643169738366CATH AKUNIV602 DXT 6F 5PK ANGIO RAD KIT
20643169738359CATH AKUNIV601 DXT 6F 5PK ANGIO RAD KIT
20643169738342CATH AKUNIV504 DXT 5F 5PK ANGIO RAD KIT
20643169738335CATH AKUNIV503 DXT 5F 5PK ANGIO RAD KIT
20643169738328CATH AKUNIV502 DXT 5F 5PK ANGIO RAD KIT
20643169738311CATH AKUNIV501 DXT 5F 5PK ANGIO RAD KIT

Trademark Results [DxTerity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DXTERITY
DXTERITY
88324666 not registered Live/Pending
27 Software U.S., Inc.
2019-03-04
DXTERITY
DXTERITY
87350066 not registered Dead/Abandoned
DxTerity Diagnostics, Inc.
2017-02-26
DXTERITY
DXTERITY
87350060 5630340 Live/Registered
DxTerity Diagnostics, Inc.
2017-02-26
DXTERITY
DXTERITY
86415894 5392172 Live/Registered
Medtronic, Inc.
2014-10-06

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