FDA UDI
In Commercial Distribution
🇺🇸 United States
Thoratec® HeartMate 3™
DI: 05415067030801
·
Model: 106522US
·
Thoratec Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Thoratec® HeartMate 3™
- Primary DI
- 05415067030801
- Version / Model
- 106522US
- Catalog Number
- 106522US
- Company Name
- Thoratec Corporation
- Labeler DUNS
- 070156955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2019-05-23
- Public Version
- 1
- Public Version Date
- 2019-05-31
- Public Version Status
- New
- Public Device Record Key
- 37b4812c-2049-4d7a-aa10-42cee984160e
Device Description
Apical Cuff
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSQ | Ventricular (assist) bypass | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47533 | Implantable ventricular circulatory assist system | A portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067030801 | GS1 | ||||
| Unit of Use | 00813024012825 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160054 | 006 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry