DEVICE: GLUCO-CARE Pen Needles (00810008216453)
Device Identifier (DI) Information
GLUCO-CARE Pen Needles
3042-GLUCO-CARE Pen Needles 29G x 12.7mm, Red, 100/bx, 50bx/cs
In Commercial Distribution
3042
MediVena, LLC
3042-GLUCO-CARE Pen Needles 29G x 12.7mm, Red, 100/bx, 50bx/cs
In Commercial Distribution
3042
MediVena, LLC
The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen device
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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44127 | Autoinjector needle |
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Needle Gauge: 29 Gauge |
Length: 12.7 Millimeter |
Device Record Status
2c8bb499-46b4-49ab-b40b-f1a632a6a741
March 20, 2025
1
March 12, 2025
March 20, 2025
1
March 12, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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00810008216460 | 50 | 00810008216453 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
4045142586
INFO@MEDIVENA.COM
INFO@MEDIVENA.COM