ViewFlex™ D087031
GUDID 05415067002082
IRVINE BIOMEDICAL, INC.
Intracardiac ultrasound imaging catheter, steerable, single-use| Primary Device ID | 05415067002082 |
| NIH Device Record Key | 84da4bfd-2b29-486a-b5df-3dd77fd456bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViewFlex™ |
| Version Model Number | Xtra |
| Catalog Number | D087031 |
| Company DUNS | 926346966 |
| Company Name | IRVINE BIOMEDICAL, 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 | |
| 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 | |
| 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 | |
| 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
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Handling Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Handling Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067002082 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133853
FDA Product Code
| OBJ | Catheter, ultrasound, intravascular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-01-12 |
Devices Manufactured by IRVINE BIOMEDICAL, INC.
| 05415067016669 - Cool Point™ | 2024-01-22 Pressure Alarm Adapter Cable |
| 05414734310659 - Therapy™ | 2020-05-01 Ablation Catheter |
| 05414734310666 - Therapy™ | 2020-05-01 Ablation Catheter |
| 05414734310680 - Therapy™ | 2020-05-01 Ablation Catheter |
| 05414734310734 - Safire™ Blu™ SP | 2020-05-01 Ablation Catheter |
| 05414734310741 - Safire™ Blu™ SP | 2020-05-01 Ablation Catheter |
| 05414734310765 - Safire™ Blu™ SP | 2020-05-01 Ablation Catheter |
| 05414734311885 - Safire™ Blu™ Duo SP | 2020-05-01 Ablation Catheter |
Trademark Results [ViewFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIEWFLEX 98387123 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2024-02-01 |
 VIEWFLEX 87383535 not registered Dead/Abandoned |
NURICON Co., Ltd. 2017-03-23 |
 VIEWFLEX 87285087 5269952 Live/Registered |
Shenzhen ViewFlex Intelligent Technology Co.,LTD 2016-12-30 |
 VIEWFLEX 77046923 3285055 Live/Registered |
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. 2006-11-17 |
 VIEWFLEX 76386852 2822177 Dead/Cancelled |
DNP Denmark A/S 2002-03-22 |
 VIEWFLEX 75704072 not registered Dead/Abandoned |
ALTINEX, INC. 1999-05-13 |
 VIEWFLEX 73735204 1539057 Dead/Cancelled |
ESHED ROBOTEC (1982) LTD. 1988-06-20 |
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