ZOOM™ RDL Radial Access System, 105cm ICTC088105R
GUDID 00812212030528
ZOOM™ RDL, 105cm with dilator
IMPERATIVE CARE, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00812212030528 |
| NIH Device Record Key | ccb8eb2e-2c66-4040-b9a6-74a5b499fc2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZOOM™ RDL Radial Access System, 105cm |
| Version Model Number | ICTC088105R |
| Catalog Number | ICTC088105R |
| 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 | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 Centimeter |
| Lumen/Inner Diameter | 0.088 Inch |
| Outer Diameter | 0.11 Inch |
| Catheter Length | 105 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 | 00812212030528 [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.
| 00812212030757 - Zoom 7X Catheter | 2025-06-17 Zoom 7X Catheter, 137cm |
| 00850032079211 - Symphony™ 16F 82cm Catheter | 2024-08-19 16F 82cm Symphony™ Catheter w/ Dilator |
| 00812212030603 - Zoom™ 6F Insert Catheter, VTK | 2024-06-26 Zoom™ 6F Insert Catheter, VTK, 140cm |
| 00812212030627 - Zoom™ 6F Insert Catheter, VRT | 2024-06-26 Zoom™ 6F Insert Catheter, VRT, 137cm |
| 00812212030696 - Zoom™ 6F Insert Catheter, SIM | 2024-06-26 Zoom™ 6F Insert Catheter, SIM, 143cm |
| 00850032079174 - Symphony™ Advance™ Long Dilator | 2024-03-12 24F Symphony™ Advance™ Long Dilator |
| 10850032079164 - Symphony™ Clot Container | 2024-02-12 Symphony Clot Container |
| 00812212030573 - ZOOM™ 88 Large Distal Platform™ Support | 2023-06-12 ZOOM™ 88 088 LDP Support, 100 cm |
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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