Stronghold PDD

GUDID 00860002529059

Stronghold anti-disconnect device for neonate/pediatric tracheostomy tubes

HAMMER-PLANE INC

Tracheostomy tube neck holder, single-use

• Primary Device ID: 00860002529059
• NIH Device Record Key: c86f155c-1a12-4bca-a255-752c46fffed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stronghold
• Version Model Number: PDD
• Catalog Number: PDD
• Company DUNS: 791765001
• Company Name: HAMMER-PLANE 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002529028 [Primary]
GS1	00860002529059 [Package]; Contains: 00860002529028; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• JAY: Support, Breathing 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: 2019-10-04
• Device Publish Date: 2019-09-26

On-Brand Devices [Stronghold]

• 00860002529059: Stronghold anti-disconnect device for neonate/pediatric tracheostomy tubes
• 00860002529042: Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a 1 inch neck flan
• 00860002529004: Stronghold anti-disconnect device for Adult Shiley Flexible and Legacy tracheostomy tubes