FDA.reportPublic FDA data

Dual Lumen Extended Length Catheter and GALT insertion kit

Primary DI
30853072007092
Brand
Dual Lumen Extended Length Catheter and GALT insertion kit
Company
CHF SOLUTIONS INC
Model
115463
Catalog number
115463
Device description
The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
Published
2018-05-24
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
MPBCatheter, Hemodialysis, Non-Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30853072007092PackageGS15In Commercial Distribution
10853072007081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085307200709230853072007092
1085307200708110853072007081

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-786-2778support@chf-solutions.com
1-855-786-2778support@nuwellis.com

Regulatory Flags#

DUNS number
790580182
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50853072007065Dual Lumen Extended Length Catheter1141531141532018-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902202427ARROWTELEFLEX INCORPORATEDMPB2024-09-06
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10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10801902213638ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213652ARROWTELEFLEX INCORPORATEDMPB2023-05-03
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10801902213690ARROWTELEFLEX INCORPORATEDMPB2023-05-03
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10801902213515ARROWTELEFLEX INCORPORATEDMPB2023-04-27
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10801902213546ARROWTELEFLEX INCORPORATEDMPB2023-04-27