TRUEplus

FDA UDI

Class II (US FDA UDI)

by Trividia Health, Inc.

Identity

Trade Name: TRUEplus FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: TRUEplus Pen Needles 31G x 5/16" FDA UDI
Model / Reference: TRUEplus Sterile Pen Needles FDA UDI
Description: TRUEplus Pen Needles 31G x 5/16" FDA UDI

Identifiers

Catalog Number: S5H01D31-050 FDA UDI
Primary DI / UDI-DI: 00021292010300 FDA UDI
510(k) Number: K143437 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 5.16 Inch FDA UDI
Needle Gauge — 31 Gauge FDA UDI

Category: Autoinjector needle

TRUEplus by Trividia Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autoinjector needle.

Unifine Ultra — OWEN MUMFORD USA INCORPORATED · Class II
MICRON, droplet pen needle — HTL STREFA S A · Class II
SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
droplet®, pen needles — HTL STREFA S A · Class II
Nano 2nd Gen — embecta Medical II LLC · Class II
BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II

Cleared under the same submission

K143437 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Trividia Health, Inc.

Sources (1)

FDA UDI e667c782-7827-470e-90df-b3c102a15193 37 fields · synced Jun 8, 2026