FDA UDI
In Commercial Distribution
🇺🇸 United States
CentriMag™
DI: 05415067042439
·
Model: CM2TR00
·
Thoratec Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CentriMag™
- Primary DI
- 05415067042439
- Version / Model
- CM2TR00
- Catalog Number
- CM2TR00
- Company Name
- Thoratec Corporation
- Labeler DUNS
- 070156955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-30
- Public Version
- 2
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- bde5ed57-ea2c-4f7c-9be3-fa51ea240e12
Device Description
System Transporter
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40596 | Electromechanical device/system transport trolley | A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067042439 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- In use/patient transp: Temp: -20°C - 60°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa. Operation of transp: Temp: 10°C - 40°C, Rel Humidity: 20% - 80%, Pressure: 70 - 110 kPa (+/- 4.5kPa)