ZIP Pen

GUDID 30614559105348

ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector

MEGADYNE MEDICAL PRODUCTS, INC.

Surgical plume evacuation system

• Primary Device ID: 30614559105348
• NIH Device Record Key: db721598-c5a0-45c3-a772-3e96b38af456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIP Pen
• Version Model Number: 252510EC
• Company DUNS: 185444825
• Company Name: MEGADYNE MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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

Customer Support Contacts

• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com
• Phone: +18015769669
• Email: megadyne.udi@megadyne.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10614559105344 [Primary]
GS1	30614559105348 [Package]; Contains: 10614559105344; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141587

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-16
• Device Publish Date: 2018-09-04

On-Brand Devices [ZIP Pen]

• 30614559104327: ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubin
• 30614559104044: ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tub
• 30614559105751: Zip Pen Extension Nozzle 5.2" (13.2 cm)
• 30614559105348: ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubin
• 30614559105324: Zip Pen Extension Nozzle 2.7" (6.8 cm)
• 10614559105757: Zip Pen Extension Nozzle 5.2" (13.2 cm)
• 10614559105344: ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubin
• 10614559105337: ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tub
• 10614559105320: Zip Pen Extension Nozzle 2.7" (6.8 cm)
• 30614559104198: Zip Pen Extension Nozzle 5.2" (13.2 cm)
• 30614559104181: Zip Pen Extension Nozzle 2.7" (6.8 cm)