Nbp-One

FDA UDI

Class II (US FDA UDI)

by Suntech Medical, Inc.

Identity

Trade Name: NBP-ONE FDA UDI
Generic Name: Blood pressure ambulatory recorder FDA UDI
Model / Reference: 91-0143-03 FDA UDI

Identifiers

Catalog Number: NJ123 FDA UDI
Primary DI / UDI-DI: 10840935109198 FDA UDI
510(k) Number: K151520 FDA UDI
FDA Product Code: DXN FDA UDI
GMDN Term: Blood pressure ambulatory recorder 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood pressure ambulatory recorder

Nbp-One by Suntech Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure ambulatory recorder.

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Mobil-O-Graph — I.E.M. GmbH · Class II
Welch Allyn — I.E.M. GmbH · Class II
Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
ABPM pro basic device — Somnomedics GmbH · Class II
CONTEC — Contec Medical Systems Co., Ltd. · Class II
ABPM cuff — I.E.M. GmbH · Class II

Cleared under the same submission

K151520 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: Suntech Medical, Inc.

Sources (1)

FDA UDI 0255b890-7b5e-411e-9252-74dc16b0c04b 35 fields · synced Jun 8, 2026