OSSEOUS- NeckFit Tube Holder

GUDID 08904428798438

Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special design to facilitate adjustment of required size, whereas Velcro ensures for ideal adhesion grip.

EON MEDITECH PRIVATE LIMITED

Tracheostomy tube neck holder, single-use

• Primary Device ID: 08904428798438
• NIH Device Record Key: d77399ff-874a-4a04-aa16-01817f603b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOUS- NeckFit Tube Holder
• Version Model Number: EA91053
• 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: true
• 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

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08904428744947 [Primary]
GS1	08904428798438 [Package]; Contains: 08904428744947; Package: Laminated Box [10 Units]; In Commercial Distribution

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

Devices Manufactured by EON MEDITECH PRIVATE LIMITED

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• 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: 2026-03-23 Shower guard is used to temporarily replace the HME during showering.
• 08904428798438 - OSSEOUS- NeckFit Tube Holder: 2026-03-23Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special design to facilitate adjustment of required size, whereas Velcro ensures for ideal adhesion grip.
• 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