ZIP Pen

GUDID 30614559104044

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

MEGADYNE MEDICAL PRODUCTS, INC.

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Primary Device ID30614559104044
NIH Device Record Keydd914e3e-7543-47d0-8674-41854a27b936
Commercial Distribution StatusIn Commercial Distribution
Brand NameZIP Pen
Version Model Number2525-10
Company DUNS185444825
Company NameMEGADYNE MEDICAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110614559104040 [Primary]
GS130614559104044 [Package]
Contains: 10614559104040
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDAPPARATUS, EXHAUST, SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-16
Device Publish Date2016-12-14

On-Brand Devices [ZIP Pen]

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

Trademark Results [ZIP Pen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZIP PEN
ZIP PEN
78308210 2927042 Dead/Cancelled
Coolpen LLC
2003-10-01

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