FDA UDI
In Commercial Distribution
🇺🇸 United States
Impella
DI: 00813502011135
·
Model: 0043-0003
·
Abiomed, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Impella
- Primary DI
- 00813502011135
- Version / Model
- 0043-0003
- Catalog Number
- 0043-0003
- Company Name
- Abiomed, Inc.
- Labeler DUNS
- 050636737
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2014-07-31
- Public Version
- 5
- Public Version Date
- 2023-06-20
- Public Version Status
- Update
- Public Device Record Key
- ddd5664c-0e26-4bc4-aef8-60c28110d9db
Device Description
Purge Cassette, 5 Pack
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 57791 | Infusion pump cassette | A sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813502011135 | GS1 | ||||
| Unit of Use | 00813502010510 | GS1 |
Customer Contacts
- Phone
- 978.777.5410
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140003 | 000 |
| P170011 | 000 |