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Cerner CareAware iBus

FDA UDI

Class II (US FDA UDI)

by Cerner Corporation

Identity

Trade Name
Cerner CareAware iBus FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Model / Reference
CareAwareiBus6 FDA UDI

Identifiers

Primary DI / UDI-DI
00853023006012 FDA UDI
510(k) Number
K093134 FDA UDI
FDA Product Code
DRG FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment clinical data interfacing software

Cerner CareAware iBus by Cerner Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Cleared under the same submission

K093134 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerner Corporation

Sources (1)

  • FDA UDI 38be81ea-3b81-4af7-9368-8c9ed4c7c855 33 fields · synced May 30, 2026