FDA UDI
In Commercial Distribution
🇺🇸 United States
PERF-GEN Pulsatile Perfusion Solution
DI: 13700911900492
·
Model: PERF-GEN/1000/US
·
INSTITUT GEORGES LOPEZ
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PERF-GEN Pulsatile Perfusion Solution
- Primary DI
- 13700911900492
- Version / Model
- PERF-GEN/1000/US
- Company Name
- INSTITUT GEORGES LOPEZ
- Labeler DUNS
- 393146183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-27
- Public Version
- 2
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- c079104f-347c-4323-a3b1-170012f7b034
Device Description
Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18004 | Donor-organ/tissue/cell preservation solution | A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23700911900499 | GS1 | Carton box | 10 | In Commercial Distribution | |
| Primary | 13700911900492 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221386 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35.6 – 77 Degrees Fahrenheit