| Primary Device ID | 10810805000078 |
| NIH Device Record Key | 6ba5b013-0777-4432-9782-3b00f41a1d00 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Belzer UW Cold Storage Solution |
| Version Model Number | BUW-002 |
| Company DUNS | 090266979 |
| Company Name | PRESERVATION SOLUTIONS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com | |
| Phone | 2627236715 |
| brader@preservationsolutions.com |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Total Volume | 2000 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810805000071 [Primary] |
| GS1 | 10810805000078 [Package] Contains: 00810805000071 Package: [5 Units] In Commercial Distribution |
| KDN | System, Perfusion, Kidney |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-22 |
| 10810805000078 | Formulated for flushing and cold storage of kidney, liver and pancreas organs. 2000 mL |
| 10810805000047 | Formulated for flushing and cold storage of kidney, liver, pancreas organs. 1000mL |
| 10810805000023 | Formulated for flushing and cold storage of kidney, liver and pancreas organs. 500 mL |