FDA UDI
In Commercial Distribution
🇺🇸 United States
Belzer UW Cold Storage Solution
DI: 00199284914773
·
Model: BUW-006
·
Bridge To Life Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Belzer UW Cold Storage Solution
- Primary DI
- 00199284914773
- Version / Model
- BUW-006
- Company Name
- Bridge To Life Ltd.
- Labeler DUNS
- 830330457
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-17
- Public Version
- 1
- Public Version Date
- 2025-06-25
- Public Version Status
- New
- Public Device Record Key
- 8855a979-ebb8-483a-9a00-a6cb44fd83c4
Device Description
For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 2000mL
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 |
| 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 | 00199284210417 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00199284914773 | GS1 |
Customer Contacts
- Phone
- (803) 545-0080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243384 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2000 | Milliliter |