AccessGUDID - DEVICE: Conveen (05708932640312)

GUDID

Device Identifier (DI) Information

Brand Name: Conveen
Version or Model: 5070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5070
Company Name: Coloplast A/S

Primary DI Number: 05708932640312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	No
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?
41052	Non-wearable urine/faecal collection bag holder	A device designed to secure a urine or faecal collection bag (e.g., intestinal ostomy bag), or a respective bag extension, in a stable position and height to an object other than the patient. It is available in a variety of designs (e.g., hanger) and may be intended to attach the bag to objects such as wheelchairs, beds, and chairs occupied by the patient, or it may be a freestanding device with bag-suspending hooks/clips (e.g., portable stand). This is a reusable 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
No Device Sizes

Device Record Status

Public Device Record Key: 762896da-6a24-4d5c-b9eb-790f068e8ccc
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708932640329	100	05708932640312		In Commercial Distribution	Shipper Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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