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Carescape

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems Information Technologies, Inc.

Identity

Trade Name
CARESCAPE FDA UDI
Generic Name
Multiple vital physiological parameter monitoring system, clinical FDA UDI
Device Name
V100 GENERIC ATO MODEL FDA UDI
Model / Reference
V100 FDA UDI
Description
V100 GENERIC ATO MODEL FDA UDI

Identifiers

Primary DI / UDI-DI
00840682103091 FDA UDI
FDA Product Code
MHX FDA UDI
MWI FDA UDI
DXN FDA UDI
DQA FDA UDI
FLL FDA UDI
GMDN Term
Multiple vital physiological parameter monitoring system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
870.2300 FDA UDI
870.1130 FDA UDI
870.2700 FDA UDI
880.2910 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple vital physiological parameter monitoring system, clinical

Carescape by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ge Medical Systems Information Technologies, Inc.

Sources (1)

  • FDA UDI 2e8851f9-b77e-400c-842b-64da95873bea 34 fields · synced Jun 8, 2026