DEVICE: Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed (04086000100991)
Device Identifier (DI) Information
Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed
4R2367
In Commercial Distribution
4R2367
Fresenius Kabi AG
4R2367
In Commercial Distribution
4R2367
Fresenius Kabi AG
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47572 | Apheresis system tubing set |
A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKT | Separator, Automated, Blood Cell, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK150288 | 0 |
BK160112 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: 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
9c1f7fba-44be-45c5-8627-9e1eba6c0767
July 06, 2018
3
September 09, 2016
July 06, 2018
3
September 09, 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 |
---|---|---|---|---|---|
14086000100998 | 6 | 04086000100991 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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