AccessGUDID - DEVICE: EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System (10815112020832)

GUDID

Device Identifier (DI) Information

Brand Name: EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System
Version or Model: 900304
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900304
Company Name: Bracco Diagnostics Inc.

Primary DI Number: 10815112020832
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849234661 *Terms of Use

Device Description: Empty Exacta l Bag

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?
14194	Enema tube	A non-sterile, length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum. It is typically a thick-walled tube and connects to the enema bag at one end and to the enema tip at the other. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FGD	Catheter, Retention, Barium Enema With Bag

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: ece23fb6-fd42-4763-9b71-2214056dc003
Public Version Date: May 26, 2025
Public Version Number: 4
DI Record Publish Date: September 19, 2016