FDA UDI
In Commercial Distribution
🇺🇸 United States
Waters IGL Pulsatile Perfusion Solution
DI: 13700911900614
·
Model: PPS/1000
·
INSTITUT GEORGES LOPEZ
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Waters IGL Pulsatile Perfusion Solution
- Primary DI
- 13700911900614
- Version / Model
- PPS/1000
- Company Name
- INSTITUT GEORGES LOPEZ
- Labeler DUNS
- 393146183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-24
- Public Version
- 1
- Public Version Date
- 2023-06-01
- Public Version Status
- New
- Public Device Record Key
- 130152b8-740a-4fa7-8760-f4ce7e4f567b
Device Description
Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys
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 | 23700911900611 | GS1 | Carton box | 10 | In Commercial Distribution | |
| Primary | 13700911900614 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221386 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit