DEVICE: HEB In-Control Insulin Syringe (00041220791422)

Device Identifier (DI) Information

HEB In-Control Insulin Syringe
79142
In Commercial Distribution
79142
H. E. BUTT GROCERY COMPANY
00041220791422
GS1

100
007924756 *Terms of Use
0.5mL 30G 5/16 (8mm) Single use insulin syringe with needle. Includes 100 sterile syringes.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
Yes
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
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
FMI Needle, Hypodermic, Single Lumen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152879 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Total Volume: 0.5 Milliliter
Length: 8 Millimeter
Needle Gauge: 30 Gauge
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Device Record Status

a0210f6c-b138-40bb-ab74-f42add79f676
July 06, 2018
3
January 04, 2017
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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: 00041220791590 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
No
No CLOSE

Customer Contact

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1-800-886-1618
info@allisonmedical.com
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