Angled Stem T-Tube with Rings

GUDID 00815347020334

Montgomery Tracheal T-Tube

HOOD, E BENSON LABORATORIES INC

Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use Basic tracheostomy tube, single-use

• Primary Device ID: 00815347020334
• NIH Device Record Key: 2717a420-c6f2-4d73-a93e-e836c7a81860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angled Stem T-Tube with Rings
• Version Model Number: ASTR-12-S
• Company DUNS: 076603380
• Company Name: HOOD, E BENSON LABORATORIES INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815347020334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873742

FDA Product Code

• BTO: Tube, Tracheostomy (W/Wo Connector)

Sterilization

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

[00815347020334]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347020334]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00815347020334]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-13

On-Brand Devices [Angled Stem T-Tube with Rings]

• 00815347020341: Montgomery Tracheal T-Tube
• 00815347020334: Montgomery Tracheal T-Tube
• 00815347020327: Montgomery Tracheal T-Tube
• 00815347020310: Montgomery Tracheal T-Tube