AccessGUDID - DEVICE: Silicone Sump Drain Tube (14710961935909)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone Sump Drain Tube
Version or Model: 2016-0320
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FORTUNE MEDICAL INSTRUMENT CORP.

Primary DI Number: 14710961935909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 656763489 *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):	No
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?
15270	Sump drain	A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBW	Catheter, Peritoneal

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
No Device Sizes

Device Record Status

Public Device Record Key: 709b10a3-3a7a-41ba-aeb8-b7640eba78c1
Public Version Date: December 23, 2021
Public Version Number: 1
DI Record Publish Date: December 15, 2021