TracStar™ Large Distal Platform ICAC088095
GUDID 00812212030399
TracStar™ LDP, 95 cm
IMPERATIVE CARE, INC.
Vascular microcatheter| Primary Device ID | 00812212030399 |
| NIH Device Record Key | f109c47b-628f-41cf-8dde-f2d134ebfce0 |
| Commercial Distribution Discontinuation | 2022-08-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TracStar™ Large Distal Platform |
| Version Model Number | ICAC088095 |
| Catalog Number | ICAC088095 |
| Company DUNS | 080816678 |
| Company Name | IMPERATIVE CARE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com | |
| Phone | 1-408-502-7548 |
| CustomerService@Imperativecare.com |
Device Dimensions
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 95 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 * Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812212030399 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212224
FDA Product Code
| DQY | Catheter, Percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-19 |
| Device Publish Date | 2022-08-11 |
On-Brand Devices [TracStar™ Large Distal Platform]
| 00812212030030 | TracStar™ 6F 088 LDP, 110 cm |
| 00812212030023 | TracStar™ 6F 088 LDP, 100 cm |
| 00812212030139 | TracStar™ 6F 088 LDP, 105 cm |
| 00812212030122 | TracStar™ 6F 088 LDP, 95 cm |
| 00812212030344 | TracStar™ LDP, 105 cm |
| 00812212030337 | TracStar™ LDP, 95 cm |
| 00812212030467 | TracStar™ LDP, 105 cm |
| 00812212030399 | TracStar™ LDP, 95 cm |
Trademark Results [TracStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACSTAR 88011918 not registered Live/Pending |
IMPERATIVE CARE, INC. 2018-06-22 |
 TRACSTAR 77850791 3806247 Dead/Cancelled |
SANOFI 2009-10-16 |
 TRACSTAR 76407141 2697678 Live/Registered |
McElroy Manufacturing, Inc. 2002-05-13 |
 TRACSTAR 75598178 not registered Dead/Abandoned |
TRACSTAR SYSTEMS, INC. 1998-12-02 |
 TRACSTAR 75598177 not registered Dead/Abandoned |
TRACSTAR SYSTEMS, INC. 1998-12-02 |
 TRACSTAR 75598176 2414543 Live/Registered |
TRACSTAR SYSTEMS, INC. 1998-12-02 |
 TRACSTAR 73408864 1283146 Dead/Cancelled |
MicroTrac Systems, Inc. 1983-01-10 |
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