← Back to catalogue

Welby

FDA UDI

Class II (US FDA UDI)

by Shenzhen Pump Medical System Co., Ltd.

Identity

Trade Name
Welby FDA UDI
Generic Name
Patient monitoring system module, blood pressure, noninvasive FDA UDI
Model / Reference
MD 14942 FDA UDI

Identifiers

Primary DI / UDI-DI
06947679701279 FDA UDI
510(k) Number
K141416 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Patient monitoring system module, blood pressure, noninvasive 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient monitoring system module, blood pressure, noninvasive

Welby by Shenzhen Pump Medical System Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, blood pressure, noninvasive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Pump Medical System Co., Ltd.

Sources (1)

  • FDA UDI 8b74b7a6-9a56-4b91-8b7b-05c2f82d2ee8 33 fields · synced May 30, 2026