DEVICE: Fetal Monitor Remote Display (B321600225000)

Download: XML | JSON

Device Identifier (DI) Information

Fetal Monitor Remote Display
27 DeskTop

CLINICOMP INTERNATIONAL, INC.
B321600225000
HIBCC
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Patient monitoring system central station monitor A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HGM System, Monitoring, Perinatal
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: less than 35 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Weight: 36 Pound
Height: 19 Inch
Width: 26 Inch
Length: 10 Inch
CLOSE

Device Status

In Commercial Distribution
September 22, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
8003508202
radine.pobuda@clinicomp.com
CLOSE