Hummingbird Tympanostomy Tube System 05-1001-653

GUDID 50853386007072

05-1001-653, +90 Inserter With Pre-loaded Vent Tube

PRECEPTIS MEDICAL, INC

Tympanostomy tube

• Primary Device ID: 50853386007072
• NIH Device Record Key: c1361dd3-3afb-433a-8d98-e1081b7c3cec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hummingbird Tympanostomy Tube System
• Version Model Number: 05-1001-653
• Catalog Number: 05-1001-653
• Company DUNS: 011948777
• Company Name: PRECEPTIS MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com
• Phone: (763) 568-7810
• Email: customerservice@preceptismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853386007077 [Primary]
GS1	50853386007072 [Package]; Contains: 00853386007077; Package: 10 Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142282

FDA Product Code

• ETD: Tube, Tympanostomy

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: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [Hummingbird Tympanostomy Tube System]

• 00853386007046: 05-1001-503, -90/-90 Inserter Assembly With Pre-loaded Vent Tube
• 00853386007053: 05-1001-502, +90/+90 Inserter Assembly With Pre-loaded Vent Tube
• 00853386007015: 05-1001-501, +90/-90 Inserter Assembly With Pre-loaded Vent Tube
• 50853386007072: 05-1001-653, +90 Inserter With Pre-loaded Vent Tube
• 50853386007065: 05-1001-652, -90 Inserter With Pre-loaded Vent Tube