DEVICE: Insulin Syringe, 1mL 31G x 8MM (00311917048130)

Device Identifier (DI) Information

Insulin Syringe, 1mL 31G x 8MM
928856
In Commercial Distribution
928856
Becton, Dickinson and Company Inc
00311917048130
GS1

100
047047543 *Terms of Use
SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
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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
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Room Temperature
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Clinically Relevant Size

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Size Type Text
Needle Gauge: 31 Gauge
Length: 8 Millimeter
Total Volume: 1 Milliliter
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Device Record Status

29e7a4bd-7685-483e-a5e2-31574c51589c
July 06, 2018
3
December 20, 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
50382909288563 5 00311917048130 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: 00382903678198 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
No CLOSE

Customer Contact

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No Customer Contact currently defined
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