AccessGUDID - DEVICE: Medline Industries (10080196036745)

GUDID

Device Identifier (DI) Information

Brand Name: Medline Industries
Version or Model: DYND72016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYND72016
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10080196036745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: TUBE, GASTRIC SUMP, 16FR, 48", 50/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:	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?
35415	Nasogastric decompression tube	A sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. It may also be used for the delivery of fluids (for irrigation, enteral feeding, and medication administration) typically for the period that gastric decompression is required. This device may be referred to as a nasogastric sump tube or a gastrointestinal decompression tube. This is a single-use device.	Active	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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 48 INCHES IN LENGTH; 16 FRENCH

Device Record Status

Public Device Record Key: 0e6ab430-7007-469e-93f6-ead1b4b68104
Public Version Date: June 17, 2019
Public Version Number: 4
DI Record Publish Date: September 29, 2016