AspireAssist A-Tube Kit 100-0011-LANG B

GUDID 10857808005037

AspireAssist A-Tube Kit

ASPIRE BARIATRICS, INC.

Gastrostomy aspiration system stomach tube

• Primary Device ID: 10857808005037
• NIH Device Record Key: 40a846f6-142b-42a6-91a8-6ebb2efdc924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AspireAssist A-Tube Kit
• Version Model Number: 100-0011-LANG B
• Catalog Number: 100-0011-LANG B
• Company DUNS: 026281163
• Company Name: ASPIRE BARIATRICS, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-312-0007
• Email: quality@aspirebariatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10857808005037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150024

FDA Product Code

• OYF: Aspiration Therapy System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-07-25

On-Brand Devices [AspireAssist A-Tube Kit]

• 10857808005471: AspireAssist A-Tube Kit
• 10857808005044: AspireAssist A-Tube Kit
• 10857808005037: AspireAssist A-Tube Kit
• 10857808005020: AspireAssist A-Tube Kit