AccessGUDID - DEVICE: Conveen Security+ (05708932539265)

GUDID

Device Identifier (DI) Information

Brand Name: Conveen Security+
Version or Model: 21027
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21027
Company Name: Coloplast A/S

Primary DI Number: 05708932539265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Conveen Security+. Urine collection bag. Leg bag. Inlet tube: 20 inch (50 cm). Clamp outlet. incl. 10 x strap set (non-sterile). Volume: 34 oz (1000 ml).

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
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?
58923	Wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNW	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

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
Length: 50 Centimeter
Total Volume: 34 Fluid Ounce
Total Volume: 1000 Milliliter
Length: 20 Inch

Device Record Status

Public Device Record Key: 4c8bdc12-b251-4c36-8517-09571268d92e
Public Version Date: November 08, 2024
Public Version Number: 2
DI Record Publish Date: March 11, 2022