Montgomery® Safe-T-Tube™ 620011

GUDID 34063107101473

Size: Extra-Long 11 mm; Type: Clear

Boston Medical Products, Inc.

Trachea prosthesis

• Primary Device ID: 34063107101473
• NIH Device Record Key: 5b6df872-b7e5-4e9d-adfe-7b95ab6e5bf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Montgomery® Safe-T-Tube™
• Version Model Number: 620011
• Catalog Number: 620011
• Company DUNS: 131855157
• Company Name: Boston Medical Products, 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: false
• 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

Customer Support Contacts

• Phone: 1-800-433-2674
• Email: info@bosmed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	14063107101479 [Primary]
GS1	34063107101473 [Package]; Contains: 14063107101479; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843936

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [Montgomery® Safe-T-Tube™]

• EBES7213100: Size:Tapered 10/13 mm; Type: Clear
• EBES7210080: Size:Tapered 8/10 mm; Type: Clear
• EBES71310R0: Size:Tapered 10/13 mm; Type: Radiopaque
• EBES71008R0: Size:Tapered 8/10 mm; Type: Radiopaque
• EBES62016R0: Size: Extra-Long 16 mm; Type: Radiopaque
• EBES62015R0: Size: Extra-Long 15 mm; Type: Radiopaque
• EBES62014R0: Size: Extra-Long 14 mm; Type: Radiopaque
• EBES62013R0: Size: Extra-Long 13 mm; Type: Radiopaque
• EBES62012R0: Size: Extra-Long 12 mm; Type: Radiopaque
• EBES62011R0: Size: Extra-Long 11 mm; Type: Radiopaque
• EBES62010R0: Size: Extra-Long 10 mm; Type: Radiopaque
• EBES6200160: Size: Extra-Long 16 mm; Type: Clear
• EBES6200150: Size: Extra-Long 15 mm; Type: Clear
• EBES6200140: Size: Extra-Long 14 mm; Type: Clear
• EBES6200130: Size: Extra-Long 13 mm; Type: Clear
• EBES6200120: Size: Extra-Long 12 mm; Type: Clear
• EBES6200110: Size: Extra-Long 11 mm; Type: Clear
• EBES6200100: Size: Extra-Long 10 mm; Type: Clear
• EBES52016R0: Size: Thoracic 16 mm; Type: Radiopaque
• EBES52015R0: Size: Thoracic 15 mm; Type: Radiopaque
• EBES52014R0: Size: Thoracic 14 mm; Type: Radiopaque
• EBES52013R0: Size: Thoracic 13 mm; Type: Radiopaque
• EBES52012R0: Size: Thoracic 12 mm; Type: Radiopaque
• EBES52011R0: Size: Thoracic 11 mm; Type: Radiopaque
• EBES52010R0: Size: Thoracic 10 mm; Type: Radiopaque
• EBES5200160: Size: Thoracic 16 mm; Type: Clear
• EBES5200150: Size: Thoracic 15 mm; Type: Clear
• EBES5200140: Size: Thoracic 14 mm; Type: Clear
• EBES5200130: Size: Thoracic 13 mm; Type: Clear
• EBES5200120: Size: Thoracic 12 mm; Type: Clear
• EBES5200110: Size: Thoracic 11 mm; Type: Clear
• EBES5200100: Size: Thoracic 10 mm; Type: Clear
• EBES42016R0: Size: Standard 16 mm; Type: Radiopaque
• EBES42015R0: Size: Standard 15 mm; Type: Radiopaque
• EBES42014R0: Size: Standard 14 mm; Type: Radiopaque
• EBES42013R0: Size: Standard 13 mm; Type: Radiopaque
• EBES42012R0: Size: Standard 12 mm; Type: Radiopaque
• EBES42011R0: Size: Standard 11 mm; Type: Radiopaque
• EBES42010R0: Size: Standard 10 mm; Type: Radiopaque
• EBES4200160: Size: Standard 16 mm; Type: Clear
• EBES4200150: Size: Standard 15 mm; Type: Clear
• EBES4200140: Size: Standard 14 mm; Type: Clear
• EBES4200130: Size: Standard 13 mm; Type: Clear
• EBES4200120: Size: Standard 12 mm; Type: Clear
• EBES4200110: Size: Standard 11 mm; Type: Clear
• EBES4200100: Size: Standard 10 mm; Type: Clear
• EBES32009R0: Size: Pediatric 9 mm; Type: Radiopaque
• EBES32008R0: Size: Pediatric 8 mm; Type: Radiopaque
• EBES32007R0: Size: Pediatric 7 mm; Type: Radiopaque
• EBES32006R0: Size: Pediatric 6 mm; Type: Radiopaque