Phantom IM-K2550-2

GUDID 00851314007007

Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 in. hg. @ sea level, 230 VAC

Innovative Med

Surgical suction system

• Primary Device ID: 00851314007007
• NIH Device Record Key: ed2e50ba-35db-4e8b-aa14-ac75af0fe7e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phantom
• Version Model Number: 2550-2
• Catalog Number: IM-K2550-2
• Company DUNS: 928308407
• Company Name: Innovative Med
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	00851314007007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895761

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [Phantom]

• 00851314007045: Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 in. hg. @ sea level, 115 VAC
• 00851314007038: Surgical Aspirator:1/3 hp. 0-3.6 scfm / 0-27.5 in. hg. @ sea level, 230 VAC
• 00851314007014: Surgical Aspirator: 1/3 hp. 0-3.6 scfm / 0-27.5 in. hg. @ sea level, 115 VAC
• 00851314007007: Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 in. hg. @ sea level, 230 VAC