ZOOM™ RDL Radial Access System, 103cm ICTC088103R
GUDID 00812212030566
ZOOM™ RDL, 103cm with dilator
IMPERATIVE CARE, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00812212030566 |
| NIH Device Record Key | 3315798f-4308-43d4-903a-a9224c82a065 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZOOM™ RDL Radial Access System, 103cm |
| Version Model Number | ICTC088103R |
| Catalog Number | ICTC088103R |
| 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
Device Dimensions
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 103 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. |
| 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. |
| 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 | 00812212030566 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220807
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 | 2022-10-06 |
| Device Publish Date | 2022-09-28 |
Devices Manufactured by IMPERATIVE CARE, INC.
| 00812212030764 - Zoom 4S Catheter | 2025-12-02 Zoom 4S Reperfusion Catheter, 160cm |
| 00812212030771 - Zoom 4S Catheter | 2025-12-02 Zoom 4S Reperfusion Catheter, 144cm |
| 00812212030788 - Zoom 4S Catheter | 2025-12-02 Zoom 4S Reperfusion Catheter, 125cm |
| 00812212030795 - Ikon 14 Guidewire | 2025-12-02 Imperative Care Neurovascular Guidewire-Standard, 0.014", 200cm |
| 00812212030801 - Ikon 14 Guidewire | 2025-12-02 Imperative Care Neurovascular Guidewire-Standard, 0.014", 300cm |
| 00812212030818 - Ikon 14 Pro Guidewire | 2025-12-02 Imperative Care Neurovascular Guidewire-Support, 0.014", 200cm |
| 00812212030825 - Ikon 14 Pro Guidewire | 2025-12-02 Imperative Care Neurovascular Guidewire-Support, 0.014", 300cm |
| 00812212030832 - Ikon 18 Guidewire | 2025-12-02 Imperative Care Neurovascular Guidewire-Standard, 0.018", 200cm |
Trademark Results [ZOOM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZOOM 98610700 not registered Live/Pending |
Zoom Bait Company, Inc. 2024-06-20 |
 ZOOM 98241199 not registered Live/Pending |
Zhang, Wei 2023-10-26 |
 ZOOM 98084430 not registered Live/Pending |
Zoom Video Communications, Inc. 2023-07-13 |
 ZOOM 97747407 not registered Live/Pending |
Liquid IP Holdings, LLC 2023-01-09 |
 ZOOM 97464841 not registered Live/Pending |
Zoom Video Communications, Inc. 2022-06-17 |
 ZOOM 97394672 not registered Live/Pending |
Michigan Mutual Inc. 2022-05-04 |
 ZOOM 97371103 not registered Live/Pending |
Xiangdong Li 2022-04-19 |
 ZOOM 90980848 not registered Live/Pending |
Zoom Video Communications, Inc. 2021-04-22 |
 ZOOM 90772404 not registered Live/Pending |
Zoom Innovations, Inc. 2021-06-14 |
 ZOOM 90665166 not registered Live/Pending |
Zoom Video Communications, Inc. 2021-04-22 |
 ZOOM 90042564 not registered Live/Pending |
Joovy Holding Co, 2020-07-08 |
 ZOOM 90033513 not registered Live/Pending |
Zoom Precision LLC 2020-07-02 |
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