Pps Pi

FDA UDI

Class II (US FDA UDI)

by Perouse Medical

Identity

Trade Name: PPS PI FDA UDI
Generic Name: Subcutaneous infusion/injection port needle FDA UDI
Device Name: Pressure Injectable Safety Huber Needle FDA UDI
Model / Reference: U202010 FDA UDI
Description: Pressure Injectable Safety Huber Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 03661234011254 FDA UDI
510(k) Number: K120261 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Subcutaneous infusion/injection port 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

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

MRI Safety

MR Conditional FDA UDI

Category: Subcutaneous infusion/injection port needle

Pps Pi by Perouse Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Subcutaneous infusion/injection port needle.

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Easy Comfort Safety Pen Needles 31G 5mm — HOME AIDE DIAGNOSTICS, INC. · Class II
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HIgH-Flo™ Needle Set — REPRO MED SYSTEMS, INC. · Class II

Cleared under the same submission

K120261 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: Perouse Medical

Sources (1)

FDA UDI 961bb4da-cf44-47d7-858c-17063baf8ac7 34 fields · synced May 31, 2026