AccessGUDID - DEVICE: AMSure® Enteral Irrigation Kit with Piston Syringe (10704411008491)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Enteral Irrigation Kit with Piston Syringe
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS126
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411008491
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Enteral Irrigation Kit with Piston Syringe Clean, Ready to Use For Single Patient Use Only CONTENTS: • Graduated Container, 500 ml • 1 Piston Irrigation Syringe, 60 ml • 1 Patient I.D. Label • 1 Luer Tip Adapter

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?
60445	Enteral feeding kit, adult/paediatric, non-sterile	A collection of non-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: No
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: 9dca71f8-57d3-4578-88d3-a336665c75ed
Public Version Date: July 06, 2018
Public Version Number: 1
DI Record Publish Date: June 05, 2018