← Back to catalogue

Carescape

FDA UDI

Class II (US FDA UDI)

by GE Healthcare Finland Oy

Identity

Trade Name
CARESCAPE FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Model / Reference
Monitor B850 CPU-C1 FDA UDI

Identifiers

Primary DI / UDI-DI
00840682105118 FDA UDI
510(k) Number
K131414 FDA UDI
FDA Product Code
OLT FDA UDI
KOI FDA UDI
DPZ FDA UDI
KRB FDA UDI
CBS FDA UDI
ORT FDA UDI
CCK FDA UDI
DRT FDA UDI
CAP FDA UDI
DXN FDA UDI
OLW FDA UDI
CBR FDA UDI
GWJ FDA UDI
OMC FDA UDI
NHQ FDA UDI
NHP FDA UDI
BZQ FDA UDI
DSK FDA UDI
NHO FDA UDI
DSI FDA UDI
DQA FDA UDI
FLL FDA UDI
DSJ FDA UDI
DPS FDA UDI
GWQ FDA UDI
MHX FDA UDI
MLD FDA UDI
BZK FDA UDI
BZL FDA UDI
CBQ FDA UDI
DQK FDA UDI
DXG FDA UDI
CCL FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
868.2775 FDA UDI
870.2710 FDA UDI
870.1915 FDA UDI
868.1620 FDA UDI
868.1400 FDA UDI
870.2300 FDA UDI
868.2600 FDA UDI
870.1130 FDA UDI
868.1700 FDA UDI
882.1900 FDA UDI
868.1500 FDA UDI
868.2375 FDA UDI
870.1110 FDA UDI
870.1025 FDA UDI
870.2700 FDA UDI
880.2910 FDA UDI
870.1100 FDA UDI
870.2340 FDA UDI
868.1850 FDA UDI
868.1730 FDA UDI
870.1425 FDA UDI
870.1435 FDA UDI
868.1720 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
MRI Safety
MR Unsafe FDA UDI

Category: General-purpose multi-parameter bedside monitor

Carescape by GE Healthcare Finland Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Cleared under the same submission

K131414 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
GE Healthcare Finland Oy

Sources (1)

  • FDA UDI bf4d18b8-3cc9-4511-816c-308aa2e159c8 35 fields · synced Jun 8, 2026