DEVICE: BD Ultra-Fine Insulin Syringes, 1/2mL x 8MM (00382908468039)

Device Identifier (DI) Information

BD Ultra-Fine Insulin Syringes, 1/2mL x 8MM
328468
In Commercial Distribution
328468
Becton, Dickinson and Company Inc
00382908468039
GS1

100
047047543 *Terms of Use
SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K024112 000
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Sterilization

Yes
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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
Length: 8 Millimeter
Needle Gauge: 31 Gauge
Total Volume: 0.5 Milliliter
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Device Record Status

4851e2af-2896-4049-bed4-ad69c4b2dd5a
July 06, 2018
3
August 03, 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
50382903284684 5 00382908468039 In Commercial Distribution Case
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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: 00382903666683 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
No
No
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Customer Contact

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No Customer Contact currently defined
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