FDA.reportPublic FDA data

CRITICATH(TM) SP5325H MONITORING CATHETER

Primary DI
50886333600569
Brand
CRITICATH(TM) SP5325H MONITORING CATHETER
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
680056
Catalog number
680056
Device description
Catheter with 5 FR, 2 Lumen, Length 80 cm
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333600569PackageGS120In Commercial Distribution
00886333600564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633360056950886333600569
00886333600564008863336005648863336005640886333600564

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery catheter, standardA flexible tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian) and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) (e.g., pulmonary arterial pressures, continuous cardiac output, stroke volume) via the pressure changes at its distal tip; it is not intended to be used for thermal dilution techniques. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
595138793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884450372382Merit Medical®108844503723852019-01-16
20884450628304Merit Medical®B6821062024-12-07
20884450360631Meritrans DTXPlus®B6820012024-09-06
10884450330750Merit Medical®00884450330753684063/A2024-01-12
20884450387768Merit Medical®10884450387761682078/B2023-04-26
20884450388161Merit Medical®10884450388164682275/B2023-03-03
10884450330798Merit Medical®00884450330791684085/A2022-09-20
20884450321502Careflow™10884450321505681631/A2022-09-20
20884450387751Merit Medical®10884450387754682075/B2022-06-16
20884450385160Meritrans DTXPlus®10884450385163682034/B2022-06-08
20884450372085Merit Medical®10884450372088682077/B2022-04-26
00884450323267Meritrans DTXPlus®10884450323264683019/A2022-03-04
20884450619289Meritrans DTXPlus®10884450619282689887/B2022-02-28
20884450619296Safedraw™10884450619299689844/B2022-02-28
20884450621152Safedraw™10884450621155689883/B2022-02-28
20884450371774Meritrans DTXPlus®10884450371777682012/B2022-02-18
10884450361037Merit Medical®00884450361030684061/A2022-01-19
20884450321885Careflow™10884450321888681718/A2022-01-10
10884450361013Merit Medical®00884450361016684045/A2020-11-13
20884450320901Critikit™10884450320904680000/A2018-01-30

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