DEVICE: Insulin Syringe, 3/10mL 31G x 8MM (00311917048154)
Device Identifier (DI) Information
Insulin Syringe, 3/10mL 31G x 8MM
928858
In Commercial Distribution
928858
Becton, Dickinson and Company Inc
928858
In Commercial Distribution
928858
Becton, Dickinson and Company Inc
SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMF | Syringe, piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K024112 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Room Temperature |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 0.3 Milliliter |
Length: 8 Millimeter |
Needle Gauge: 31 Gauge |
Device Record Status
74afda48-89d8-40e6-b9d7-8b77c1972574
July 06, 2018
3
December 20, 2016
July 06, 2018
3
December 20, 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 |
---|---|---|---|---|---|
50382909288587 | 5 | 00311917048154 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00382903678358
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined