AccessGUDID - DEVICE: Ulti-Flo General Purpose Drainage Catheter (H862LBL2T1630HB0)

GUDID

Device Identifier (DI) Information

Brand Name: Ulti-Flo General Purpose Drainage Catheter
Version or Model: LBL2T-1630HB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LBL2T-1630HB
Company Name: URESIL, LLC

Primary DI Number: H862LBL2T1630HB0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F

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: 16 French
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 29ec5694-59b7-4ff3-b0dc-b804fa1c95a9
Public Version Date: April 28, 2022
Public Version Number: 2
DI Record Publish Date: June 09, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862LBL2T1630HB1	5	H862LBL2T1630HB0	2022-04-27	Not in Commercial Distribution	Dispenser
H862LBL2T1630HB2	4	H862LBL2T1630HB1	2022-04-27	Not in Commercial Distribution	Shipper