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eCareManager

FDA UDI

Class II (US FDA UDI)

by Visicu, Inc.

Identity

Trade Name
eCareManager FDA UDI
Generic Name
Patient health record information system application software FDA UDI
Device Name
Telehealth Center Product License FDA UDI
Model / Reference
4.7 FDA UDI
Description
Telehealth Center Product License FDA UDI

Identifiers

Catalog Number
865325 FDA UDI
Primary DI / UDI-DI
00884838115460 FDA UDI
510(k) Number
K211046 FDA UDI
FDA Product Code
MSX FDA UDI
GMDN Term
Patient health record information system application 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient health record information system application software

eCareManager by Visicu, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient health record information system application software.

Cleared under the same submission

K211046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Visicu, Inc.

Sources (1)

  • FDA UDI 8bdc070e-68f9-4ef1-86cf-e5449c027b0c 36 fields · synced Jun 8, 2026