FDA.reportPublic FDA data

Thermodilution 7FR 110cm Modified J-tip

Primary DI
M822474110P0
Brand
Thermodilution 7FR 110cm Modified J-tip
Company
ALPHA MEDICAL INSTRUMENTS
Model
474-110P
Catalog number
474-110P
Device description
Thermodilution Catheter
Published
2016-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYGCatheter, Flow Directed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920869000FLOW DIRECTED THERMODILUTION BALLOON CATHETERJ-Lloyd Medical, Inc.1993-01-13DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M822474110P0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery catheter, thermal dilutionA flexible tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein and advanced to the pulmonary artery, to measure/monitor haematological parameters (e.g., pulmonary arterial pressures, intermittent cardiac output, cardiac index) using thermal dilution techniques; it may also be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included], and includes an exit port for the solution and an electrical component (e.g., thermistor) for temperature measurements. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-460-0944info@alphamedicalinstruments.com

Regulatory Flags#

DUNS number
627767577
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M822162110PS2Wedge Pressure 6fr 110cm S-tip 162-110PS162-110PS2016-11-10
M82214260P2Wedge Pressure 4fr 60cm Modified J-tip 142-60P142-60P2016-11-10
M822152110P0Wedge Pressure 5fr 110cm Modified J-tip(Standard-tip)152-110P152-110P2016-10-08
M82215260P2Wedge Pressure 5fr 60cm Modified J-tip 152-60P152-60P2016-11-10
M822162110PS0Wedge Pressure  6fr 110cm S-tip162-110PS162-110PS2016-10-08
M82216280P0Wedge Pressure  6fr 110cm Standard Tip162-80P162-80P2016-10-08
M82216280P2Wedge Pressure  6fr 80cm Modified J-tip162-80P162-80P2016-10-08
M822172110PS2Wedge Pressure 7fr 110cm S-tip172-110PS172-110PS2016-11-10
M82217290P2Wedge Pressure 7fr 90cm Modified J-tip 172-90P172-90P2016-11-10
M82225280P2Angiographic 5fr 80cm C-tip252-80P252-80P2016-11-10
M822606002Bipolar 5FR 110cm Modified-J Shrouded Pins606002652/1-110P2017-03-03
M8226521110P0Bipolar 5FR 110cm Modified-J Shrouded Pins652/1-110P625/1-110P2016-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
50690103218287SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
50690103218638SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103217094Swan-GanzEdwards Lifesciences LLCDYG2025-07-11
00690103219371SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219388SWAN-GANZEdwards Lifesciences LLCDYG2024-08-05
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