DEVICE: Plastic Storage Container (04086000100175)
Device Identifier (DI) Information
Plastic Storage Container
X6R2350
In Commercial Distribution
X6R2350
Fresenius Kabi AG
X6R2350
In Commercial Distribution
X6R2350
Fresenius Kabi AG
Sterile Fluid Path.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKT | Separator, Automated, Blood Cell, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK990009 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Product Should be Handled and Stored according to Guidelines for the Component Collected. Store at Room Temperature. Protect from freezing. Avoid excessive heat. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0cf629eb-f232-40c5-b95c-dfae90dc585b
July 06, 2018
3
September 02, 2016
July 06, 2018
3
September 02, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
24086000100179 | 7 | 14086000100172 | In Commercial Distribution | Carton | |
14086000100172 | 4 | 04086000100175 | In Commercial Distribution | Inner Pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined