FDA UDI
In Commercial Distribution
🇺🇸 United States
Custodiol(R)
DI: 04033133611016
·
Model: 6 x 1000 ml
·
Dr. Franz Köhler Chemie GmbH
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Custodiol(R)
- Primary DI
- 04033133611016
- Version / Model
- 6 x 1000 ml
- Company Name
- Dr. Franz Köhler Chemie GmbH
- Labeler DUNS
- 316512953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2019-08-08
- Public Version
- 2
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- d03e2740-8ca4-4dc3-ae2d-3504255d7313
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 |
|---|---|---|---|---|
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | Gastroenterology, Urology | 876.5880 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04033133611016 | GS1 | ||||
| Unit of Use | 04033133011014 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light
- Type
- Storage Environment Temperature
- Temperature Range
- 35.6 – 46.4 Degrees Fahrenheit