AccessGUDID - DEVICE: Coloplast (05708932702676)

GUDID

Device Identifier (DI) Information

Brand Name: Coloplast
Version or Model: 14070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14070
Company Name: Coloplast A/S

Primary DI Number: 05708932702676
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Coloplast Fistula and Wound Management System / Coloplast . without filter. 1 Fistula and Wound Manager Maxi. 1 Fistula Flexible Lid Maxi without filter. 1 Tracing guide. 1 Transparent cover sheet. 1 Fistula Drain Port. 1 Clamp. 1 Pump per retail box. Maxi. Fistula and Wound Manager Size Maxi.

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):	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?
31075	One-piece intestinal ostomy bag, open-ended	A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FON	BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

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
Special Storage Condition, Specify: This way up.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Fistula and Wound Manager Size Maxi

Device Record Status

Public Device Record Key: ac0db6c6-3143-484b-aeb1-45b03bc80235
Public Version Date: March 21, 2022
Public Version Number: 1
DI Record Publish Date: March 11, 2022