AccessGUDID - DEVICE: Rounded Flexi Tip Adult Enema Tip (10815112021167)

GUDID

Device Identifier (DI) Information

Brand Name: Rounded Flexi Tip Adult Enema Tip
Version or Model: 901301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901301
Company Name: Bracco Diagnostics Inc.

Primary DI Number: 10815112021167
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 849234661 *Terms of Use

Device Description: Rounded Flexi Tip

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?
11583	Enema tip, single-use	A device intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum; it is not intended to be used during colonic irrigation. It is typically designed as a one-piece, synthetic polymer, moulded nozzle that may have a slight bulb shape at the distal end to improve retention in the rectum. This is a single-use 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: 70cefba4-1b3c-49bc-ab3f-d8271305f0b5
Public Version Date: May 26, 2025
Public Version Number: 2
DI Record Publish Date: May 25, 2023