BP Pump 2M

FDA UDI

Class II (US FDA UDI)

by Fluke Electronics Corporation

Identity

Trade Name: BP Pump 2M FDA UDI
Generic Name: Noninvasive blood pressure physical simulator FDA UDI
Device Name: Non-Invasive Blood Pressure Simulator and Tester FDA UDI
Model / Reference: BPPUMP2M-US120V FDA UDI
Description: Non-Invasive Blood Pressure Simulator and Tester FDA UDI

Identifiers

Catalog Number: 2249049 FDA UDI
Primary DI / UDI-DI: 00850540007201 FDA UDI
510(k) Number: K921074 FDA UDI
FDA Product Code: DXN FDA UDI
GMDN Term: Noninvasive blood pressure physical simulator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1130 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

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

FDA UDI

Category: Noninvasive blood pressure physical simulator

BP Pump 2M by Fluke Electronics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K921074 also covers:

BP Pump 2L — FLUKE ELECTRONICS CORPORATION

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: Fluke Electronics Corporation

Sources (1)

FDA UDI 8cca9b00-7e33-4522-a96f-ddb67d1deade 36 fields · synced May 30, 2026