← Back to catalogue

GoWISE USA

FDA UDI

Class II (US FDA UDI)

by Ming's Mark Inc.

Identity

Trade Name
GoWISE USA FDA UDI
Generic Name
Physiologic-monitoring defibrillation system FDA UDI
Model / Reference
GW22063 FDA UDI

Identifiers

Primary DI / UDI-DI
00819687020115 FDA UDI
FDA Product Code
OFE FDA UDI
OED FDA UDI
GMDN Term
Physiologic-monitoring defibrillation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1140 FDA UDI
870.1120 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
MRI Safety
MR Safe FDA UDI

Category: Physiologic-monitoring defibrillation system

GoWISE USA by Ming's Mark Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physiologic-monitoring defibrillation system.

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
Ming's Mark Inc.

Sources (1)

  • FDA UDI 13d1d571-0a6d-4f32-8f4d-63c16733809a 32 fields · synced Jun 1, 2026