FDA UDI
In Commercial Distribution
🇺🇸 United States
Impella
DI: 00813502011401
·
Model: 0042-0040-US
·
Abiomed, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Impella
- Primary DI
- 00813502011401
- Version / Model
- 0042-0040-US
- Catalog Number
- 0042-0040-US
- Company Name
- Abiomed, Inc.
- Labeler DUNS
- 050636737
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-31
- Public Version
- 1
- Public Version Date
- 2023-08-08
- Public Version Status
- New
- Public Device Record Key
- c0a0139f-49cf-4086-90d5-3980625aa03b
Device Description
Optical, AIC, Impella Connect, Pkgd, US
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular | 870.4360 | 3 |
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57808 | Intracardiac circulatory assist axial-pump catheter control unit | A mains electricity (AC-powered) device designed to operate and monitor an intracardiac circulatory assist axial-pump catheter (e.g., a catheter with integrated micro motor and impeller) to provide circulatory assistance to the heart by pumping blood during heart failure. It typically consists of operator controls, a monitoring interface, a low-voltage connection to drive the impeller, a fluid purging pump, and provides backup power when line power is not available during transport. It is typically used emergently [e.g., post acute myocardial infarction (AMI)] or electively when haemodynamic support is necessary. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813502011401 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140003 | 000 |
| P170011 | 000 |