AccessGUDID - DEVICE: Ulti-Flo General Purpose Drainage Catheter (H862LBNL2050H0)

GUDID

Device Identifier (DI) Information

Brand Name: Ulti-Flo General Purpose Drainage Catheter
Version or Model: LBNL-2050H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LBNL-2050H
Company Name: URESIL, LLC

Primary DI Number: H862LBNL2050H0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: HYDROPHILIC COATED LARGE BORE NON-LOCKING CATHETER, 20F

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBO	Catheter, Nephrostomy, General & Plastic Surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 20 French
Length: 41 Centimeter

Device Record Status

Public Device Record Key: 38fa76ae-6ad0-4d7f-959b-a0bd5827c00b
Public Version Date: December 20, 2022
Public Version Number: 4
DI Record Publish Date: August 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862LBNL2050H2	4	H862LBNL2050H1	2025-09-30	In Commercial Distribution	Shipper
H862LBNL2050H1	5	H862LBNL2050H0	2025-09-30	Not in Commercial Distribution	Dipsenser