DEVICE: Monoject (10192253064308)

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Device Record History
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Device Identifier (DI) Information
Monoject
8881613130
In Commercial Distribution
8881613130
Cardinal Health 200, LLC
10192253064308
GS1

1
961027315 *Terms of Use
Monoject™ 0.3 mL Insulin Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38501 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, piston
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K151949 000
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 31 Gauge
Total Volume: 0.3 Milliliter
Length: 6 Millimeter
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Device Record Status
bd159133-d877-4947-8647-3612dfa907c8
May 08, 2024
2
March 01, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20192253064305 100 10192253064308 In Commercial Distribution BOX
50192253064306 5 20192253064305 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
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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No Customer Contact currently defined
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