Aware

FDA UDI

Class II (US FDA UDI)

by Ambient Clinical Analytics

Identity

Trade Name: AWARE FDA UDI
Generic Name: Clinical management support software FDA UDI
Model / Reference: 1.1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850893007002 FDA UDI
510(k) Number: K143372 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Clinical management support software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Clinical management support software

Aware by Ambient Clinical Analytics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K143372 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: Ambient Clinical Analytics

Sources (1)

FDA UDI e8121220-40ac-41db-8346-170d2b40bd44 33 fields · synced May 30, 2026