FDA UDI
In Commercial Distribution
🇺🇸 United States
CentriMag™
DI: 07640135140627
·
Model: 102953
·
Thoratec Switzerland GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CentriMag™
- Primary DI
- 07640135140627
- Version / Model
- 102953
- Catalog Number
- 102953
- Company Name
- Thoratec Switzerland GmbH
- Labeler DUNS
- 486066918
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 6
- Public Version Date
- 2023-03-24
- Public Version Status
- Update
- Public Device Record Key
- 3ffe6e3f-392f-44ba-9a4f-e1744448ff06
Device Description
Blood Pump
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Cardiovascular | 870.4360 | 2 |
| QNR | Blood pump for ECMO, long-term (> 6 hours) use | Cardiovascular | 870.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31718 | Cardiopulmonary bypass system centrifugal pump | A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640135140627 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius