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Morpheus

FDA UDI

Class II (US FDA UDI)

by Blackrock Neuromed, Llc

Identity

Trade Name
MORPHEUS FDA UDI
Generic Name
Electroencephalography telemetric monitoring system FDA UDI
Device Name
Micromed MORPHEUS Amplifer for HOME LTM. FDA UDI
Model / Reference
NM-0354 FDA UDI
Description
Micromed MORPHEUS Amplifer for HOME LTM. FDA UDI

Identifiers

Catalog Number
NM-0354 FDA UDI
Primary DI / UDI-DI
00850154007079 FDA UDI
510(k) Number
K071782 FDA UDI
FDA Product Code
GWL FDA UDI
GWQ FDA UDI
OLV FDA UDI
GWK FDA UDI
GMDN Term
Electroencephalography telemetric monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1835 FDA UDI
882.1400 FDA UDI
882.1845 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

Yes

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

No

FDA UDI

Category: Electroencephalography telemetric monitoring system

Morpheus by Blackrock Neuromed, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalography telemetric monitoring system.

Cleared under the same submission

K071782 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Blackrock Neuromed, Llc

Sources (1)

  • FDA UDI f439412e-a770-490a-a100-b156d9ef1940 36 fields · synced Jun 8, 2026