DxTerity™ Angio-Kit

GUDID 20643169738304

CATH AKSTAN602 DXT 6F 5PK ANGIO STD KIT

MEDTRONIC, INC.

Angiographic catheter, single-use
Primary Device ID20643169738304
NIH Device Record Keyf20dbc86-c16a-4e9b-9fdc-26f79e95a40c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDxTerity™ Angio-Kit
Version Model NumberAKSTAN602
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
GS100643169738300 [Primary]
GS120643169738304 [Package]
Contains: 00643169738300
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™ Angio-Kit]

20643169738304CATH AKSTAN602 DXT 6F 5PK ANGIO STD KIT
20643169738298CATH AKSTAN601 DXT 6F 5PK ANGIO STD KIT
20643169738281CATH AKSTAN502 DXT 5F 5PK ANGIO STD KIT
20643169738274CATH AKSTAN501 DXT 5F 5PK ANGIO STD 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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