DEVICE: GLUCO-CARE Insulin Syringes (00810008215791)

Device Identifier (DI) Information

GLUCO-CARE Insulin Syringes
GLUCO-CARE Insulin Syringes 0.3ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b
In Commercial Distribution
2242
MediVena, LLC
00810008215791
GS1

1
080740980 *Terms of Use
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Total Volume: 0.3 Milliliter
Needle Gauge: 30 Gauge
Length: 8 Millimeter
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Device Record Status

3674ff46-77a9-4e62-90df-fed493523fc4
February 24, 2025
1
February 15, 2025
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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
00810008215807 100 00810008215791 In Commercial Distribution box
00810008216996 20 00810008215807 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
4045142586
info@medivena.com
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