FDA UDI
In Commercial Distribution
🇺🇸 United States
Impella
DI: 00813502012811
·
Model: 1000323
·
Abiomed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Impella
- Primary DI
- 00813502012811
- Version / Model
- 1000323
- Catalog Number
- 1000323
- Company Name
- Abiomed, Inc.
- Labeler DUNS
- 050636737
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-15
- Public Version
- 2
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- 966a3eaf-e5f9-4f6e-ae48-7389f9d1085a
Device Description
RP Flex w Smart Assist Set, 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56732 | Intracardiac circulatory assist axial-pump catheter | A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery, and connected to an external control unit; it moves blood from the left ventricle to the aorta across the aortic valve. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and during transport between hospitals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813502012811 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170011 | 039 |