DEVICE: Custodiol(R) (04033133610002)
Device Identifier (DI) Information
Custodiol(R)
6 x 1000 ml
In Commercial Distribution
Dr. Franz Köhler Chemie GmbH
6 x 1000 ml
In Commercial Distribution
Dr. Franz Köhler Chemie GmbH
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KDL | Set, Perfusion, Kidney, Disposable |
| KDN | System, Perfusion, Kidney |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K020924 | 000 |
| K032794 | 000 |
| K043461 | 000 |
| K992209 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 35.6 and 46.4 Degrees Fahrenheit |
| Special Storage Condition, Specify: Protect from light |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8d5feee1-09fd-4e9f-b371-bf1b3334b8a1
December 08, 2022
2
May 09, 2019
December 08, 2022
2
May 09, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
04033133010000
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined