| Primary Device ID | 08904428798421 |
| NIH Device Record Key | 769279bb-ac00-4b77-ad18-1c5e8572eac0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSEOUS- ShowerProtect |
| Version Model Number | EA91051 |
| Company DUNS | 930270428 |
| Company Name | EON MEDITECH PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 25 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 0 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08904428744916 [Primary] |
| GS1 | 08904428798421 [Package] Contains: 08904428744916 Package: Laminated box [1 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-23 |
| Device Publish Date | 2026-03-13 |
| 00890446104932 - OSSEOUS-Endoscrub 4 mm ( 0° ) | 2026-03-23 The Endo scrub is a single-use, sterile, accessory device designed for use with rigid endoscopes. It is a surgical tool, a devic |
| 08904428745326 - OSSEOUS- Skin Closure Tape | 2026-03-23 |
| 08904428745333 - OSSEOUS- Skin Preparation Pad | 2026-03-23 The Skin preparation pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and |
| 08904428798421 - OSSEOUS- ShowerProtect | 2026-03-23Shower guard is used to temporarily replace the HME during showering. |
| 08904428798421 - OSSEOUS- ShowerProtect | 2026-03-23 Shower guard is used to temporarily replace the HME during showering. |
| 08904428798438 - OSSEOUS- NeckFit Tube Holder | 2026-03-23 Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special des |
| 08904428798483 - OSSEOUS- Tube Cleaning Brush - 8mm | 2026-03-23 The tube cleaning brush is used to clean Laryngectomy tube &Laryngectomy button |
| 08904428798469 - OSSEOUS-Cleaning Pad | 2026-03-23 |
| 08904428799749 - OSSEOUS- Adhesion Remover Pad | 2026-03-23 The Adhesive removal pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and |