AccessGUDID - DEVICE: Provox StabiliBase OptiDerm (15 pcs) (07331791009037)

GUDID

Device Identifier (DI) Information

Brand Name: Provox StabiliBase OptiDerm (15 pcs)
Version or Model: 7318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7318
Company Name: Atos Medical AB

Primary DI Number: 07331791009037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.

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):	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?
62175	Removable ambulatory appliance skin-adherent patch	A patch with a pressure-sensitive adhesive coating designed to be adhered to the skin to temporarily secure/affix a removable patient-worn ambulatory appliance (e.g., tracheostomy base plate, insulin infusion pump) to the body. It is made of synthetic polymer materials [e.g., polyurethane] and is available in various designs (e.g., round, slot, spiral, with a central opening to fit the wearable appliance). It is not intended to adhere an external aesthetic restoration prosthesis (e.g., artificial nose, breast prosthesis) to the skin surface. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight.
Storage Environment Temperature: between 2 and 42 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b92cd4f-233b-4fb0-9177-8a6b929871b5
Public Version Date: November 25, 2024
Public Version Number: 6
DI Record Publish Date: July 13, 2022