MOND™ 4150/60
GUDID 05414734505451
Stylet kit, wide curve
ST. JUDE MEDICAL, INC.
Pacing/defibrillation lead stylet| Primary Device ID | 05414734505451 |
| NIH Device Record Key | 4d6d9841-577e-4852-a977-ebe13593d22a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOND™ |
| Version Model Number | RVOT STYLET |
| Catalog Number | 4150/60 |
| Company DUNS | 790268031 |
| Company Name | ST. JUDE MEDICAL, 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 | true |
| Expiration Date | true |
| 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
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from extreme temperatures, humidity, and water. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734505451 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080924
FDA Product Code
| DRB | STYLET, CATHETER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-10 |
On-Brand Devices [MOND™ ]
| 05414734505451 | Stylet kit, wide curve |
| 05414734505444 | Stylet Kit, medium curve |
| 05414734505437 | Stylet kit, wide curve |
| 05414734505420 | Stylet Kit, medium curve |
| 05414734504072 | Stylet kit, wide curve |
| 05414734504065 | Stylet kit, wide curve |
| 05414734504058 | Stylet kit, wide curve |
| 05414734504041 | Stylet kit, wide curve |
| 05414734504034 | Stylet Kit, medium curve |
| 05414734504027 | Stylet Kit, medium curve |
| 05414734504010 | Stylet Kit, medium curve |
| 05414734504003 | Stylet Kit, medium curve |
| 05414734503419 | Stylet kit, wide curve |
| 05414734503402 | Stylet kit, wide curve |
| 05414734503396 | Stylet Kit, medium curve |
| 05414734502702 | Stylet Kit, medium curve |
Trademark Results [MOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOND 87071026 5197271 Live/Registered |
Philippe Schaedler 2016-06-14 |
 MOND 78226520 not registered Dead/Abandoned |
European Cigarette Imports, Inc. 2003-03-17 |
 MOND 77123910 3540939 Live/Registered |
Pacesetter, Inc. 2007-03-06 |
 MOND 77042626 3873670 Dead/Cancelled |
TELMAP LTD. 2006-11-13 |
 MOND 73000195 1018018 Dead/Expired |
MOND PLASTICS, INC. 1973-09-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.