AccessGUDID - DEVICE: AMSure ® Enteral Administration Kit (10704411016151)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure ® Enteral Administration Kit
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ENF500K2
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411016151
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: Enteral Administration Kit FOR USE WITH AMSure® ENTERAL FEEDING PUMP CONTENTS: -Enteral Feeding 500 mL Bag Pump Set with ENFit Connector -ENFit Transition 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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
64461	Enteral feeding noninvasive-component set	A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. 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
No Device Sizes

Device Record Status

Public Device Record Key: ee3f0803-c1cf-4a09-a904-a39724d1b061
Public Version Date: June 01, 2023
Public Version Number: 1
DI Record Publish Date: May 24, 2023