PeriCam PSI HR

FDA UDI

Class II (US FDA UDI)

by Perimed, Inc.

Identity

Trade Name: PeriCam PSI HR FDA UDI
Generic Name: Laser Doppler blood flowmeter FDA UDI
Device Name: PeriCam PSI HR FDA UDI
Model / Reference: PSI HR FDA UDI
Description: PeriCam PSI HR FDA UDI

Identifiers

Primary DI / UDI-DI: 07332834000165 FDA UDI
510(k) Number: K120884 FDA UDI
FDA Product Code: DPW FDA UDI
GMDN Term: Laser Doppler blood flowmeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laser Doppler blood flowmeter

PeriCam PSI HR by Perimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K120884 also covers:

PeriCam PSI NR — Perimed, Inc.

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: Perimed, Inc.

Sources (1)

FDA UDI 826d324f-b678-441a-85c3-d7fc0f9eae8a 35 fields · synced Jun 6, 2026