Wells Johnson Elite Infiltrator/Aspirator 20-5061-00

GUDID B458205061000

Wells Johnson Elite Infiltrator/Aspirator, 110-120VAC 50Hz, 115-120VAC 60Hz

The Wells Johnson Company

Surgical suction pump

• Primary Device ID: B458205061000
• NIH Device Record Key: 93360f71-cb33-4077-b7d0-ca0a9cbb9ba7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wells Johnson Elite Infiltrator/Aspirator
• Version Model Number: 20506100
• Catalog Number: 20-5061-00
• Company DUNS: 048931625
• Company Name: The Wells Johnson Company
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B458205061000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832274

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-28
• Device Publish Date: 2023-11-20

On-Brand Devices [Wells Johnson Elite Infiltrator/Aspirator]

• B458205066000: Wells Johnson Elite Infiltrator/Aspirator, 220-240VAC 50Hz, 230-240VAC 60Hz
• B458205061000: Wells Johnson Elite Infiltrator/Aspirator, 110-120VAC 50Hz, 115-120VAC 60Hz