FDA UDI
In Commercial Distribution
🇺🇸 United States
Waters IGL Pulsatile Perfusion Solution
DI: 00810805000170
·
Model: PPS/1000/US
·
PRESERVATION SOLUTIONS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Waters IGL Pulsatile Perfusion Solution
- Primary DI
- 00810805000170
- Version / Model
- PPS/1000/US
- Company Name
- PRESERVATION SOLUTIONS INC
- Labeler DUNS
- 090266979
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-22
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- e01a802a-6a4c-4d5a-84f5-06cbfd1c4ad0
Device Description
Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | 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 | 10810805000177 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00810805000170 | GS1 |
Customer Contacts
- Phone
- 2627236715
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080432 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1000 | Milliliter |