FDA UDI
In Commercial Distribution
🇺🇸 United States
SynCardia Companion 2 Driver
DI: 00858000003107
·
Model: 397002-001
·
SYNCARDIA SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SynCardia Companion 2 Driver
- Primary DI
- 00858000003107
- Version / Model
- 397002-001
- Company Name
- SYNCARDIA SYSTEMS, LLC
- Labeler DUNS
- 080414145
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6c33b8bd-d326-41d5-826e-0000a3ad9faf
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LOZ | Artificial Heart | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16977 | Artificial heart, temporary | A sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly as a bridge to heart transplantation. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858000003107 | GS1 |
Customer Contacts
- Phone
- 8667719437
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030011 | 011 |
| P030011 | 013 |
| P030011 | 015 |
| P030011 | 022 |
| P030011 | 023 |
| P030011 | 027 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar