AccessGUDID - DEVICE: AMSure® Enteral Feeding Irrigation Tray (10704411011095)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Enteral Feeding Irrigation Tray
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ENK136T
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411011095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Enteral Feeding Irrigation Tray CONTENTS: 1000cc Outer Tray 500cc Graduated Container 60cc Thumb Control Ring Piston Syringe with ENFit Tip ENFit transition connector Protective cap Alcohol Prep Pad Large Moisture-Proof Underpad

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?
11677	Enteral feeding kit, adult/paediatric, sterile	A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. 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: 0949a34f-a426-40e1-8414-5aad3ee82907
Public Version Date: August 20, 2019
Public Version Number: 1
DI Record Publish Date: August 12, 2019