FDA UDI
In Commercial Distribution
🇺🇸 United States
Kidney Assist Transport
DI: 08719925460517
·
Model: Kidney Assist Transport
·
XVIVO B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kidney Assist Transport
- Primary DI
- 08719925460517
- Version / Model
- Kidney Assist Transport
- Catalog Number
- 23.101
- Company Name
- XVIVO B.V.
- Labeler DUNS
- 489176113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-04
- Public Version
- 1
- Public Version Date
- 2022-05-12
- Public Version Status
- New
- Public Device Record Key
- 0bf747b9-fd1a-4892-b6e0-c3234dbf16d1
Device Description
The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient.
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 |
|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33479 | Kidney donor-organ preservation/transport system | A dedicated system designed to support and maintain a donated kidney 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 |
|---|---|---|---|---|---|---|
| Primary | 08719925460517 | GS1 |
Customer Contacts
- Phone
- +310503131905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211333 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal