ZOOM™ Reperfusion Catheter ICRC045144
GUDID 00812212030276
ZOOM 045 144 cm RC
IMPERATIVE CARE, INC.
Thrombectomy suction catheter| Primary Device ID | 00812212030276 |
| NIH Device Record Key | bce21625-ad79-4c37-8bbe-766d3db0b12d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZOOM™ Reperfusion Catheter |
| Version Model Number | ICRC045144 |
| Catalog Number | ICRC045144 |
| 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 | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
| Lumen/Inner Diameter | 0.045 Inch |
| Outer Diameter | 0.062 Inch |
| Catheter Length | 144 Centimeter |
Operating and Storage Conditions
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812212030085 [Previous] |
| GS1 | 00812212030276 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202182
FDA Product Code
| NRY | Catheter, Thrombus Retriever |
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 | 2020-12-01 |
| Device Publish Date | 2020-11-23 |
On-Brand Devices [ZOOM™ Reperfusion Catheter]
| 00812212030085 | ZOOM 045 144 cm RC |
| 00812212030078 | ZOOM 055 137 cm RC |
| 00812212030092 | ZOOM 035 158 cm RC |
| 00812212030061 | ZOOM 071 137 cm RC |
| 00812212030191 | ZOOM 071 137 cm RC |
| 00812212030184 | ZOOM 035 158 cm RC |
| 00812212030207 | ZOOM 035 160 cm RC |
| 00812212030276 | ZOOM 045 144 cm RC |
| 00812212030283 | ZOOM 055 137 cm RC |
| 00812212030450 | ZOOM 071 137 cm RC |
| 00812212030443 | ZOOM 035 160 cm RC |
| 00812212030498 | ZOOM 045 144 cm RC |
| 00812212030474 | ZOOM 055 137 cm RC |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.