AccessGUDID - DEVICE: NeoDevices, Inc. (10816340022063)

GUDID

Device Identifier (DI) Information

Brand Name: NeoDevices, Inc.
Version or Model: ND36EOY
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEODEVICES INC

Primary DI Number: 10816340022063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 189670230 *Terms of Use

Device Description: 36" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector

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":	No
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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 00a92387-f2bb-49e0-a307-1c2404e60a6a
Public Version Date: December 23, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016