TracStar™ Large Distal Platform ICAC088105

GUDID 00812212030139

TracStar™ 6F 088 LDP, 105 cm

IMPERATIVE CARE, INC.

Vascular microcatheter
Primary Device ID00812212030139
NIH Device Record Key2e50f11c-1b33-4846-af13-f14a4f5a1bbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracStar™ Large Distal Platform
Version Model NumberICAC088105
Catalog NumberICAC088105
Company DUNS080816678
Company NameIMPERATIVE CARE, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com
Phone1-408-502-7548
EmailCustomerService@Imperativecare.com

Device Dimensions

Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter
Lumen/Inner Diameter0.088 Inch
Outer Diameter0.108 Inch
Catheter Length90 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Device Identifiers

Device Issuing AgencyDevice ID
GS100812212030139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-08
Device Publish Date2019-04-30

On-Brand Devices [TracStar™ Large Distal Platform]

00812212030030TracStar™ 6F 088 LDP, 110 cm
00812212030023TracStar™ 6F 088 LDP, 100 cm
00812212030139TracStar™ 6F 088 LDP, 105 cm
00812212030122TracStar™ 6F 088 LDP, 95 cm
00812212030344TracStar™ LDP, 105 cm
00812212030337TracStar™ LDP, 95 cm
00812212030467TracStar™ LDP, 105 cm
00812212030399TracStar™ LDP, 95 cm

Trademark Results [TracStar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRACSTAR
TRACSTAR
88011918 not registered Live/Pending
IMPERATIVE CARE, INC.
2018-06-22
TRACSTAR
TRACSTAR
77850791 3806247 Dead/Cancelled
SANOFI
2009-10-16
TRACSTAR
TRACSTAR
76407141 2697678 Live/Registered
McElroy Manufacturing, Inc.
2002-05-13
TRACSTAR
TRACSTAR
75598178 not registered Dead/Abandoned
TRACSTAR SYSTEMS, INC.
1998-12-02
TRACSTAR
TRACSTAR
75598177 not registered Dead/Abandoned
TRACSTAR SYSTEMS, INC.
1998-12-02
TRACSTAR
TRACSTAR
75598176 2414543 Live/Registered
TRACSTAR SYSTEMS, INC.
1998-12-02
TRACSTAR
TRACSTAR
73408864 1283146 Dead/Cancelled
MicroTrac Systems, Inc.
1983-01-10

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