DEVICE: TRUEplus (00096295129113)

Device Identifier (DI) Information

TRUEplus
TRUEplus Pen Needles 31 GAUGE x 1/4"
In Commercial Distribution
S5002C31-100
TRIVIDIA HEALTH, INC.
00096295129113
GS1

100
151810868 *Terms of Use
LEADER TRUEplus Pen Needles 31 GAUGE x 1/4"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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
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

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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 [?]
K143437 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
Length: 0.25 Inch
Needle Gauge: 31 Gauge
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Device Record Status

d5e809b5-80f3-4292-9b35-087049f07d74
July 06, 2018
3
September 22, 2016
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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
50096295129118 30 00096295129113 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: 00021292009007 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)803-6025
customercare@trividiahealth.com
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