FDA UDI
In Commercial Distribution
🇺🇸 United States
Twin Transfer Set
DI: 04250273756067
·
Model: 9 D
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Twin Transfer Set
- Primary DI
- 04250273756067
- Version / Model
- 9 D
- Catalog Number
- 2890701
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-11
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- 77d79016-2a97-4943-b95c-7b9d6ff0be6f
Device Description
For transition of irrigation solution.
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34930 | Single-administration urethral drainage/irrigation catheter | A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04250273756074 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 04250273756067 | GS1 |
Customer Contacts
- Phone
- +496621168400
- [email protected]