FDA UDI
In Commercial Distribution
🇺🇸 United States
CentriMag™
DI: 07640135140474
·
Model: 102961
·
Thoratec Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CentriMag™
- Primary DI
- 07640135140474
- Version / Model
- 102961
- Catalog Number
- 102961
- Company Name
- Thoratec Corporation
- Labeler DUNS
- 070156955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 9
- Public Version Date
- 2026-01-26
- Public Version Status
- Update
- Public Device Record Key
- 0f47b1f0-9831-4f4c-ad2a-6259920f339d
Device Description
Motor Bracket 45°
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
- 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 |
|---|---|---|---|---|
| KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61434 | Portable active medical device mount | A device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640135140474 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Environment Atmospheric Pressure: 79.3kPa - 101.3kPa and 595mmHg - 760mmHg; Handling Environment Atmospheric Pressure: 79.3kPa - 101.3kPa and 595mmHg - 760mmHg