Firmm®

FDA UDI

Class II (US FDA UDI)

by Turing Medical Technologies, Inc.

Identity

Trade Name: FIRMM® FDA UDI
Generic Name: MRI system application software FDA UDI
Device Name: Framewise Integrated Real-Time MRI Monitoring FDA UDI
Model / Reference: v5 FDA UDI
Description: Framewise Integrated Real-Time MRI Monitoring FDA UDI

Identifiers

Catalog Number: FIRMM® FDA UDI
Primary DI / UDI-DI: 00860004785101 FDA UDI
510(k) Number: K201141 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: MRI system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 155 Millimeter FDA UDI
Width — 65 Millimeter FDA UDI
Height — 206 Millimeter FDA UDI

Category: MRI system application software

Firmm® by Turing Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Turing Medical Technologies, Inc.

Sources (1)

FDA UDI d6cb73d1-1ac1-436b-adaa-dc86667d99d2 37 fields · synced May 30, 2026