FDA UDI
In Commercial Distribution
🇺🇸 United States
Transfer Pack Container with Coupler - 2000 mL
DI: 04052682039171
·
Model: 4R2041
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Transfer Pack Container with Coupler - 2000 mL
- Primary DI
- 04052682039171
- Version / Model
- 4R2041
- Catalog Number
- 4R2041
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-24
- Public Version
- 1
- Public Version Date
- 2022-07-04
- Public Version Status
- New
- Public Device Record Key
- 92f05125-e43e-4ca2-acc1-788224c97521
Device Description
Transfer Pack container with Coupler 2000 mL for processing and/or storage of blood or blood components.
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
- Yes
- 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 |
|---|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Hematology | 864.9100 | 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 | 04052682039164 | GS1 | Carton | 48 | In Commercial Distribution | |
| Primary | 04052682039171 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature. Protect from freezing. Avoid excessive heat.