AccessGUDID - DEVICE: Medline Industries (10080196837939)

GUDID

Device Identifier (DI) Information

Brand Name: Medline Industries
Version or Model: DYND70324
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYND70324
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10080196837939
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: TUBE,GASTROSTOMY,24FR,3-PORT,WHITE,1/CS

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?
58891	Gastrostomy tube Y-piece connector	A connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. It has two resealable ports intended for flushing the line and/or administering medications without the need for tube disconnection or interruption of an enteral feed. It is typically made of plastic materials and is available in a range of sizes. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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
Device Size Text, specify: 15 CUBIC CENTIMETERS IN VOLUME; 24 FRENCH

Device Record Status

Public Device Record Key: cff8f00f-0b20-4bc4-a54a-eef5418fe40d
Public Version Date: December 23, 2019
Public Version Number: 3
DI Record Publish Date: November 07, 2016