OSSEOUS- ShowerProtect

Basic Information

• Brand Name: OSSEOUS- ShowerProtect
• Primary DI: 08904428744916
• Version / Model: EA91051
• Company Name: EON MEDITECH PRIVATE LIMITED
• Labeler DUNS: 930270428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-13
• Public Version: 1
• Public Version Date: 2026-03-23
• Public Version Status: New
• Public Device Record Key: 769279bb-ac00-4b77-ad18-1c5e8572eac0

Device Description

Shower guard is used to temporarily replace the HME during showering.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
Package	08904428798421	GS1	Laminated box	1	In Commercial Distribution
Primary	08904428744916	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 25 – Degrees Celsius