AccessGUDID - DEVICE: AMSure® Cleansing Enema Set (10704411008378)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Cleansing Enema Set
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS330
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411008378
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Cleansing Enema Set CONTENTS: 1, One (1) each 1500 mL Enema Bag: -Pre-lubricated Tip - Tubing Clamp 2, Moisture Proof Drape 3, Enema Soap Packet

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?
35050	Gravity enema set	A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCE	Enema Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: d690f5d9-29e0-43c8-bab6-929694422247
Public Version Date: July 06, 2018
Public Version Number: 1
DI Record Publish Date: June 05, 2018