AccessGUDID - DEVICE: Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit (10853072007234)

GUDID

Device Identifier (DI) Information

Brand Name: Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit
Version or Model: 320112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 320112
Company Name: Nuwellis Inc.

Primary DI Number: 10853072007234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790580182 *Terms of Use

Device Description: This Kit includes a dELC Catheter (15cm) 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46979	Double-lumen haemodialysis catheter, nonimplantable	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQJ	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Working Length: 15 Centimeter

Device Record Status

Public Device Record Key: dcdd9329-9e44-4932-b02d-49635554390e
Public Version Date: February 28, 2024
Public Version Number: 1
DI Record Publish Date: February 20, 2024