DEVICE: APOTECA (05060304050021)

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Device Identifier (DI) Information

APOTECA
ASN-10

AEA SRL
05060304050021
GS1
1
Pharmacy compounding dosing device
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hazardous fluid syringe A sterile device designed to promote the safe (leak-free) handling of fluids and medications that are potentially hazardous or cytotoxic, such as those used for chemotherapy, radioactive isotopes, or blood products. It consists of a calibrated hollow barrel (cylinder) connected to a needle-free port (valve), and a moveable plunger used to aspirate and expel the fluid into and out of the cylinder. It is typically made of plastic and silicone materials and used for drug/fluid preparation, for their administration to the patient, and for waste handling of the expended device. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FMF Syringe, Piston
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
July 13, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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