ICU Medical

Primary DI
10840619030084
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
50472
Catalog number
50472-01
Device description
TriOx™ ScvO2 Central Venous Oximetry Catheter, Heparin Coated
Published
2021-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQECatheter, oximeter, fiber-optic

Product Code Classifications

CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840619030084PackageGS110In Commercial Distribution
00840619030087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061903008410840619030084
00840619030087008406190300878406190300870840619030087

GMDN Terms

TermDefinition
Pulmonary artery balloon catheter, oximetricA flexible tube with an inflatable balloon at its distal tip designed for measuring pulmonary arterial pressures and mixed venous oxygen saturation (SvO2) levels when connected to an appropriate oximetric patient monitor; it may also measure pulmonary artery wedge pressure. It uses a fibreoptic bundle and light-emitting diodes (LEDs) which using light emitted at two or three different wavelengths (e.g., red or near infrared) from the catheter and reflected back from the red blood cells provide the measurements. It is used in emergencies, for monitoring critically ill patients (e.g., acute respiratory failure, severe head injury) and during surgical procedures. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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