FDA.reportPublic FDA data

Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit

Primary DI
30853072007221
Brand
Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit
Company
Nuwellis Inc.
Model
320111
Catalog number
320111
Device description
This Kit includes a dELC Catheter (11cm) and a GALT Insertion Kit. The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically for use with the Aquadex systems. The catheter is inserted into the peripheral venous circulation by way of a peel away introducer.
Published
2024-02-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPBCatheter, Hemodialysis, Non-Implanted
NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2
NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral UseGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233515000Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)Nuwellis, Inc.2023-12-26NQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30853072007221PackageGS15In Commercial Distribution
10853072007210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085307200722130853072007221
1085307200721010853072007210

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length11Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
10853072007173Dual Lumen Extended Length Catheter (15cm)3201023201022024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit3201113201112024-02-20
10853072007289AquaFlexFlow UF 500 Plus - 24 Hr2101042101042021-11-23
10853072007159Dual Lumen Extended Length Catheter (11cm)3201013201012024-02-20
10853072007104Aquadex SmartFlow Console1201001201002020-03-03
10853072007111AquaFlexFlow UF 500 Plus1141561141562020-03-03
10853072007128AquaFlexFlow UF 5001141571141572020-03-03
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit3201123201122024-02-20
30853072007184Dual Lumen Extended Length Catheter (15cm)3201023201022024-02-20
30853072007245Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit3201123201122024-02-20
30853072007306AquaFlexFlow UF 500 Plus - 24 Hr2101042101042021-11-23
10853072007029Blood Circuit SetUF 500-HCT1141562018-02-22
10853072007043Dual Lumen Extended Length Catheter1141531141532018-08-16
10853072007081Dual Lumen Extended Length Catheter and GALT insertion kit1154631154632018-05-24
30853072007030Blood Circuit SetUF 500-HCT1141562018-02-22
10853072007074Aquadex FlexFlow1141581141582018-01-11
10853072007005Blood Circuit SetUF 5001141572018-02-22

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Primary DI, Brand, Company table
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10853072007173Dual Lumen Extended Length Catheter (15cm)Nuwellis Inc.NQJ2024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion KitNuwellis Inc.NQJ2024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion KitNuwellis Inc.NQJ2024-02-20
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