FDA UDI
In Commercial Distribution
🇺🇸 United States
MEGA 7.5 Fr. 30cc IAB W/O Statlock (APA) - INDIA
DI: 10607567111322
·
Model: 0684-00-0294-08
·
DATASCOPE CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEGA 7.5 Fr. 30cc IAB W/O Statlock (APA) - INDIA
- Primary DI
- 10607567111322
- Version / Model
- 0684-00-0294-08
- Catalog Number
- 0684-00-0294-08
- Company Name
- DATASCOPE CORP.
- Labeler DUNS
- 001660786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2021-12-06
- Public Version Status
- Update
- Public Device Record Key
- e0eec629-4bb6-4d9e-9c6e-3bb2b55dd1c2
Device Description
MEGA 7.5 Fr. 30cc IAB W/O Statlock (APA) - INDIA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | Cardiovascular | 870.3535 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34919 | Intra-aortic balloon catheter | A flexible, balloon-tipped, tube that is placed in the aorta distal to the aortic valve to augment the heart's pumping capability. It is typically introduced percutaneously via one of the femoral arteries and advanced to the descending thoracic aorta using fluoroscopic imaging guidance. Once positioned, an external pump alternately inflates and deflates the balloon in a cycle counter to the cardiac cycle (counter pulsation), facilitating ejection during systole and limits regurgitation during diastole. It is used to treat several cardiovascular conditions, e.g., after open-heart surgery, cardiogenic shock, intractable angina, or to reduce myocardial conditions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607567111322 | GS1 |
Customer Contacts
- Phone
- 888-627-8383
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 7.5 | French |