Provox Life Shower

Basic Information

• Brand Name: Provox Life Shower
• Primary DI: 07331791011375
• Version / Model: 8308
• Catalog Number: 8308
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-12
• Public Version: 1
• Public Version Date: 2022-07-20
• Public Version Status: New
• Public Device Record Key: ee93318d-b888-45c1-9449-b9ee2c1507a4

Device Description

Provox Life Shower is a single patient use device intended to be placed into a Provox Life attachment to protect the tracheostoma from water during showering.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	868.5375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62047	Tracheostoma shower shield	A non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. It is typically in the form of a waterproof bib worn around the patient’s neck. This is a reusable device intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07331791011375	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 42 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 108 Degrees Fahrenheit