FDA UDI
In Commercial Distribution
🇺🇸 United States
Impella
DI: 04260113630259
·
Model: 0042-0002
·
Abiomed, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Impella
- Primary DI
- 04260113630259
- Version / Model
- 0042-0002
- Catalog Number
- 0042-0002
- Company Name
- Abiomed, Inc.
- Labeler DUNS
- 050636737
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 1
- Public Version Date
- 2023-06-27
- Public Version Status
- New
- Public Device Record Key
- 5b03aaec-5430-49db-9ef5-fa468945fc50
Device Description
Sterile Connector Cable Pump / IMC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown | 3 | |
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | Cardiovascular | 870.4360 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47143 | Electrical-only medical device connection cable, single-use | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260113630259 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140003 | 000 |
| P170011 | 000 |