FDA UDI
In Commercial Distribution
🇺🇸 United States
OCS Liver System
DI: B00950480
·
Model: 3000
·
TRANSMEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OCS Liver System
- Primary DI
- B00950480
- Version / Model
- 3000
- Catalog Number
- 3000
- Company Name
- TRANSMEDICS, INC.
- Labeler DUNS
- 084445043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-01
- Public Version
- 1
- Public Version Date
- 2021-12-09
- Public Version Status
- New
- Public Device Record Key
- f6c811bf-174a-4137-bd9b-61fcd3fb4b60
Device Description
OCS Liver Console
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
- 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 |
|---|---|---|---|---|
| QQK | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42919 | Liver donor-organ preservation/transport system | A dedicated system designed to support and maintain a donated liver organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B00950491 | HIBCC | Wooden Crate | 1 | In Commercial Distribution | |
| Primary | B00950480 | HIBCC |
Customer Contacts
- Phone
- 978-552-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200031 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17 | Inch | |
| Height | 29 | Inch | |
| Width | 28 | Inch |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius