FDA.report

C.O. accessory kit (12Pin)

Primary DI
06944904006451
Brand
C.O. accessory kit (12Pin)
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
6800-30-50617
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications

CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06944904006451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06944904006451069449040064516944904006451

GMDN Terms

TermDefinition
Patient monitoring system module, cardiac outputA small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module.

Sterilization Methods

Method

Contacts

PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags

DUNS number
654671304
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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