AccessGUDID - DEVICE: Accogent LLC (01618125157357)

GUDID

Device Identifier (DI) Information

Brand Name: Accogent LLC
Version or Model: 29499
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TIDI PRODUCTS, LLC

Primary DI Number: 01618125157357
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 063519193 *Terms of Use

Device Description: Accogent LLC Urology Drain Bags Vinyl Sterile Fits Siemens Uroskop Access 20 per Case

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):	No
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?
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMZ	TABLE, CYSTOMETRIC, ELECTRIC

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: 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: eaeda319-7637-431b-911b-cc713b4278fa
Public Version Date: March 01, 2023
Public Version Number: 5
DI Record Publish Date: October 12, 2016