AccessGUDID - DEVICE: Kumar Catheter® (B361CC0190)

GUDID

Device Identifier (DI) Information

Brand Name: Kumar Catheter®
Version or Model: CC019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC-019
Company Name: NASHVILLE SURGICAL INSTRUMENTS, LLC

Primary DI Number: B361CC0190
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030096122 *Terms of Use

Device Description: The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free.

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:	Yes
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?
62668	Laparoscopic cholangiography injection catheter/needle	A flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBZ	Catheter, Cholangiography

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973621	000

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 Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 45 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b243bd66-2330-4f16-ad1a-0f037f481d94
Public Version Date: May 03, 2024
Public Version Number: 4
DI Record Publish Date: August 15, 2017