FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LifeSPARC
DI: 00814112020906
·
Model: 5900-0012
·
CARDIACASSIST, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LifeSPARC
- Primary DI
- 00814112020906
- Version / Model
- 5900-0012
- Catalog Number
- 5900-0012
- Company Name
- CARDIACASSIST, INC.
- Labeler DUNS
- 948683941
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-10
- Public Version
- 3
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 78500342-d7f3-4a2b-9e8b-690ae140f24f
- Distribution End Date
- 2024-12-06
Device Description
IV Pole Clamp for blood pump controller
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | Cardiovascular | 870.4380 | 2 |
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | Cardiovascular | 870.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33317 | Cardiopulmonary bypass system centrifugal pump drive unit | A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814112020906 | GS1 |
Customer Contacts
- Phone
- 18003737421
- [email protected]
- Phone
- +14129637770
- [email protected]