FDA UDI
In Commercial Distribution
🇺🇸 United States
THORATEC® PVAD™, VENTRICULAR CANNULA - EXTRA LONG, STRAIGHT, BLUNT TIP
DI: 00813024012245
·
Model: 14816-2569-000
·
Thoratec Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- THORATEC® PVAD™, VENTRICULAR CANNULA - EXTRA LONG, STRAIGHT, BLUNT TIP
- Primary DI
- 00813024012245
- Version / Model
- 14816-2569-000
- Catalog Number
- 14816-2569-000
- 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
- 7
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 0b2391eb-51bc-4323-b020-82c7fa1e4a40
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
- Yes
- Has Lot/Batch Number
- No
- 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 (Assisst) Bypass | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61750 | Implantable ventricular circulatory assist system inflow cannula, synthetic polymer | An implantable tube intended to function as an inflow for an implantable ventricular circulatory assist system, to channel blood from the left ventricle to the implanted system pump. It is made of a synthetic polymer(s) and does not include biologically-derived materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813024012245 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius