iHealth

FDA UDI

Class II (US FDA UDI)

by Ihealth Lab Inc.

Identity

Trade Name: iHealth FDA UDI
Generic Name: Noninvasive blood pressure physical simulator FDA UDI
Model / Reference: BP5S FDA UDI

Identifiers

Primary DI / UDI-DI: 00850044118021 FDA UDI
510(k) Number: K171062 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Noninvasive blood pressure physical simulator

iHealth by Ihealth Lab Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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iHealth — IHEALTH LAB INC. · Class II
iHealth — IHEALTH LAB INC. · Class II

Cleared under the same submission

K171062 also covers:

iHealth — IHEALTH LAB 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: Ihealth Lab Inc.

Sources (1)

FDA UDI 75f7c550-c942-4beb-b44b-2f82a891a710 33 fields · synced May 31, 2026