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Carescape B450

FDA UDI

Class II (US FDA UDI)

by GE Healthcare Finland Oy

Identity

Trade Name
CARESCAPE B450 FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
CARESCAPE B450 MBA313 FDA UDI
Model / Reference
MBA313 FDA UDI
Description
CARESCAPE B450 MBA313 FDA UDI

Identifiers

Primary DI / UDI-DI
00840682142380 FDA UDI
510(k) Number
K191249 FDA UDI
FDA Product Code
FLL FDA UDI
DPS FDA UDI
MLD FDA UDI
DQK FDA UDI
NHO FDA UDI
BZL FDA UDI
DPZ FDA UDI
DSJ FDA UDI
DXG FDA UDI
OMC FDA UDI
CBR FDA UDI
DSK FDA UDI
CBQ FDA UDI
BZQ FDA UDI
BZK FDA UDI
KOI FDA UDI
KRB FDA UDI
ORT FDA UDI
DXN FDA UDI
DQA FDA UDI
CCL FDA UDI
CCK FDA UDI
OLW FDA UDI
NHQ FDA UDI
OLT FDA UDI
NHP FDA UDI
DSI FDA UDI
MHX FDA UDI
CBS FDA UDI
GWQ FDA UDI
CAP FDA UDI
DRT FDA UDI
GWJ FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

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

No

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 B450 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GE Healthcare Finland Oy

Sources (1)

  • FDA UDI ea78578c-c2d6-492e-b582-a9196aa1dc50 36 fields · synced May 29, 2026