AccessGUDID - DEVICE: Ch24 round silicone catheter (M640R99000990001)

GUDID

Device Identifier (DI) Information

Brand Name: Ch24 round silicone catheter
Version or Model: 000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R9900099
Company Name: RAND SPA

Primary DI Number: M640R99000990001
Issuing Agency: HIBCC
Commercial Distribution End Date: February 03, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 655010531 *Terms of Use

Device Description: No description.

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?
47796	Multi-purpose percutaneous abdominothoracic drainage catheter	A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GBX	Catheter, Irrigation

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
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 600 Millimeter
Catheter Gauge: 24 French

Device Record Status

Public Device Record Key: 064729b2-9ac3-4a96-8546-59c4e0d2432b
Public Version Date: June 22, 2022
Public Version Number: 5
DI Record Publish Date: January 27, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M640R99000990002	10	M640R99000990001	2020-02-03	Not in Commercial Distribution	White box
M640R99000990003	4	M640R99000990002	2020-02-03	Not in Commercial Distribution	Havana box
M640R99000990004	2	M640R99000990002	2020-02-03	Not in Commercial Distribution	Havana box