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.

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• 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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