FDA UDI
In Commercial Distribution
🇺🇸 United States
Plastic Storage Container
DI: 04086000100175
·
Model: X6R2350
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Plastic Storage Container
- Primary DI
- 04086000100175
- Version / Model
- X6R2350
- Catalog Number
- X6R2350
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0cf629eb-f232-40c5-b95c-dfae90dc585b
Device Description
Sterile Fluid Path.
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 |
|---|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | Hematology | 864.9245 | 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 |
|---|---|---|---|---|---|---|
| Primary | 04086000100175 | GS1 | ||||
| Package | 24086000100179 | GS1 | Carton | 7 | In Commercial Distribution | |
| Package | 14086000100172 | GS1 | Inner Pack | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK990009 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Product Should be Handled and Stored according to Guidelines for the Component Collected. Store at Room Temperature. Protect from freezing. Avoid excessive heat.