Dale 200 One Piece Holder 200

GUDID H84102002

Dale One Piece tracheostomy tube holder, 1" wide neckband, fits 9.5" to 18" neck.

DALE MEDICAL PRODUCTS, INC.

Tracheostomy tube neck holder, reusable

• Primary Device ID: H84102002
• NIH Device Record Key: e9255e5b-2591-46f9-a8ab-3e5e35786ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dale 200 One Piece Holder
• Version Model Number: 200
• Catalog Number: 200
• Company DUNS: 001061233
• Company Name: DALE MEDICAL PRODUCTS, INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H84102001 [Primary]
HIBCC	H84102002 [Package]; Contains: H84102001; Package: Box [30 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: 2018-09-27
• Device Publish Date: 2018-08-27

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