ZUMA®
GUDID 00613994785084
CATHETER ZM6SCR35 ZM 6F 100CM SCR35
MEDTRONIC, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00613994785084 |
| NIH Device Record Key | d43f650b-5d8b-4611-a0a0-7b168a542ada |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZUMA® |
| Version Model Number | ZM6SCR35 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 100 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994785084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K981198
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2016-04-22 |
On-Brand Devices [ZUMA®]
| 00613994789891 | CATHETER ZT7EBU375SH ZM 7F 100CM EB375 |
| 00613994789747 | CATHETER ZM9EBU45 ZM 9F 100CM EB45 |
| 00613994789730 | CATHETER ZM9EBU45SH ZM 9F 100CM EB45 |
| 00613994789723 | CATHETER ZM9EBU50 ZM 9F 100CM EB50 |
| 00613994789716 | CATHETER ZM9EBU50SH ZM 9F 100CM EB50 |
| 00613994789709 | CATHETER ZM9ELGAMAL ZM 9F 100CM EG |
| 00613994789693 | CATHETER ZM9FL35 ZM 9F 100CM FL35 |
| 00613994789686 | CATHETER ZM9FL35SH ZM 9F 100CM FL35 |
| 00613994789679 | CATHETER ZM9FL40 ZM 9F 100CM FL40 |
| 00613994789662 | CATHETER ZM9FL40SH ZM 9F 100CM FL40 |
| 00613994789655 | CATHETER ZM9FL50 ZM 9F 100CM FL50 |
| 00613994789648 | CATHETER ZM9FL50SH ZM 9F 100CM FL50 |
| 00613994789631 | CATHETER ZM9FR40 ZM 9F 100CM FR40 |
| 00613994789624 | CATHETER ZM9FR40SH ZM 9F 100CM FR40 |
| 00613994789617 | CATHETER ZM9HSI ZM 9F 100CM HSI |
| 00613994789600 | CATHETER ZM9HSII ZM 9F 100CM HSII |
| 00613994789594 | CATHETER ZM9HSIIISH ZM 9F 100CM HSIII |
| 00613994789587 | CATHETER ZM9HSIISH ZM 9F 100CM HSII |
| 00613994789570 | CATHETER ZM9HSISH ZM 9F 100CM HSI |
| 00613994789563 | CATHETER ZM9HSISHD ZM 9F 90CM HSI |
| 00613994789556 | CATHETER ZM9IMA ZM 9F 100CM IMA |
| 00613994789549 | CATHETER ZM9IMAD ZM 9F 90CM IMA |
| 00613994789532 | CATHETER ZM9IMASH ZM 9F 100CM IMA |
| 00613994789525 | CATHETER ZM9JCL35 ZM 9F 100CM JCL35 |
| 00613994789518 | CATHETER ZM9EBU40SH ZM 9F 100CM EB40 |
| 00613994789501 | CATHETER ZM9BOVN ZM 9F 100CM BOVN |
| 00613994789495 | CATHETER ZM9STRD ZM 9F 90CM STR |
| 00613994789488 | CATHETER ZM9V1M ZM 9F 88CM V1 |
| 00613994789471 | CATHETER ZM9AL10 ZM 9F 100CM AL10 |
| 00613994789464 | CATHETER ZM9AL10SH ZM 9F 100CM AL10 |
| 00613994789457 | CATHETER ZM9AL15 ZM 9F 100CM AL15 |
| 00613994789440 | CATHETER ZM9AL15SH ZM 9F 100CM AL15 |
| 00613994789433 | CATHETER ZM9AL20 ZM 9F 100CM AL20 |
| 00613994789426 | CATHETER ZM9AL20SH ZM 9F 100CM AL20 |
| 00613994789419 | CATHETER ZM9AL30 ZM 9F 100CM AL30 |
| 00613994789402 | CATHETER ZM9AL40 ZM 9F 100CM AL40 |
| 00613994789396 | CATHETER ZM9AL75 ZM 9F 100CM AL75 |
| 00613994789389 | CATHETER ZM9AL75SH ZM 9F 100CM AL75 |
| 00613994789372 | CATHETER ZM9ALR12SH ZM 9F 100CM ALR12 |
| 00613994789365 | CATHETER ZM9AR10 ZM 9F 100CM AR10 |
| 00613994789358 | CATHETER ZM9AR10SH ZM 9F 100CM AR10 |
| 00613994789341 | CATHETER ZM9AR20 ZM 9F 100CM AR20 |
| 00613994789334 | CATHETER ZM9AR20SH ZM 9F 100CM AR20 |
| 00613994789327 | CATHETER ZM9EBU35 ZM 9F 100CM EB35 |
| 00613994789310 | CATHETER ZM9EBU35SH ZM 9F 100CM EB35 |
| 00613994789303 | CATHETER ZM9EBU375 ZM 9F 100CM EB375 |
| 00613994789297 | CATHETER ZM9EBU375SH ZM 9F 100CM EB375 |
| 00613994789280 | CATHETER ZM9EBU40 ZM 9F 100CM EB40 |
| 00613994789273 | CATHETER ZM9JCL35SH ZM 9F 100CM JCL35 |
| 00613994789266 | CATHETER ZM9LCBD ZM 9F 90CM LCB |
Trademark Results [ZUMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZUMA 98823966 not registered Live/Pending |
HiveMind Beverage LLC 2024-10-28 |
 ZUMA 98549419 not registered Live/Pending |
Cutlery and More LLC 2024-05-14 |
 ZUMA 98258504 not registered Live/Pending |
Azumi Limited 2023-11-07 |
 ZUMA 97198718 not registered Live/Pending |
Big Industries Inc. 2021-12-31 |
 ZUMA 97156722 not registered Live/Pending |
Resident Boost, Inc. 2021-12-07 |
 ZUMA 90067238 not registered Live/Pending |
STRYVE FOODS, LLC 2020-07-22 |
 ZUMA 88635888 not registered Live/Pending |
Zuma Array Limited 2019-09-30 |
 ZUMA 87752556 not registered Live/Pending |
GRIGORIUS HOLDINGS, SIA 2018-01-11 |
 ZUMA 87710779 5835475 Live/Registered |
EBSCO Gulf Coast Development, Inc. 2017-12-06 |
 ZUMA 87264902 not registered Live/Pending |
Bell Green Trading Ltd 2016-12-12 |
 ZUMA 87254820 not registered Dead/Abandoned |
Alodeh, Mohammed 2016-12-02 |
 ZUMA 87184613 5203925 Live/Registered |
Zuma Technologies LLC 2016-09-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.