DEVICE: Comfort Assist Insulin Syringe (00070030510749)

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Device Identifier (DI) Information

Comfort Assist Insulin Syringe
102912

L PERRIGO COMPANY
00070030510749
GS1
10
1cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 10ct
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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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
Insulin syringe/needle, basic A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. 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
FMI Needle, Hypodermic, Single Lumen
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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
Total Volume: 1 Milliliter
Needle Gauge: 29 Gauge
Length: 12.7 Millimeter
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Device Status

In Commercial Distribution
September 24, 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: 10070030510746 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
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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