AccessGUDID - DEVICE: ACTIVELIFE (00768455102419)

GUDID

Device Identifier (DI) Information

Brand Name: ACTIVELIFE
Version or Model: 175765
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455102419
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2022
Device Count: 15
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 1 3/4 in (45 mm)

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:	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?
31066	One-piece intestinal ostomy bag, closed-ended	A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZQ	Pouch, Colostomy

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: e0fa20bd-9db4-4e3b-99a4-73b79a7d52d6
Public Version Date: May 23, 2022
Public Version Number: 3
DI Record Publish Date: November 09, 2018