FDA UDI
In Commercial Distribution
🇺🇸 United States
Leukoconnect
DI: 04052682004308
·
Model: 4C4300
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Leukoconnect
- Primary DI
- 04052682004308
- Version / Model
- 4C4300
- Catalog Number
- 4C4300
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-02
- Public Version
- 1
- Public Version Date
- 2022-06-10
- Public Version Status
- New
- Public Device Record Key
- d39bbd14-5202-4037-b250-7c0952610f3f
Device Description
LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive 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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44903 | Blood transfer set | A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14052682004305 | GS1 | Carton | 30 | In Commercial Distribution | |
| Primary | 04052682004308 | GS1 | ||||
| Previous | 00811137010486 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK020008 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Protect from freezing. Avoid excessive heat.