Tracheal Tube Introducer (Bougie), Size 14FR, OD 4.7mm PA210114

GUDID 06923310903165

Hangzhou Formed Medical Devices Co.Ltd.

Endotracheal tube introducer, single-use

• Primary Device ID: 06923310903165
• NIH Device Record Key: 2069a9a8-4503-4241-b7d0-e360e68963af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tracheal Tube Introducer (Bougie), Size 14FR, OD 4.7mm
• Version Model Number: PA210114
• Catalog Number: PA210114
• Company DUNS: 560463769
• Company Name: Hangzhou Formed Medical Devices Co.Ltd.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06923310903165 [Primary]

FDA Product Code

• BSR: Stylet, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by Hangzhou Formed Medical Devices Co.Ltd.

• 06923310902892 - Intubating Stylet, Size 14FR, OD 4.7mm: 2022-12-14
• 06923310903141 - Tracheal Tube Introducer (Bougie), Size 6FR, OD 2.0mm: 2022-12-14
• 06923310903158 - Tracheal Tube Introducer (Bougie), Size 10FR, OD 3.3mm: 2022-12-14
• 06923310903165 - Tracheal Tube Introducer (Bougie), Size 14FR, OD 4.7mm: 2022-12-14
• 06923310903165 - Tracheal Tube Introducer (Bougie), Size 14FR, OD 4.7mm: 2022-12-14
• 06923310903172 - Tracheal Tube Introducer (Bougie), Size 15FR, OD 5.0mm: 2022-12-14