57525334

GUDID 30845854061934

FUMOVAC Speculum tube set, 2.44m, sterile

Conmed Corporation

Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube
Primary Device ID30845854061934
NIH Device Record Keycf3ef9b0-bbdb-4777-941f-9557232b298f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number57525334
Catalog Number57525334
Company DUNS071595540
Company NameConmed Corporation
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845854061933 [Unit of Use]
GS120845854061937 [Primary]
GS130845854061934 [Package]
Contains: 20845854061937
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

GAZTUBING, NONINVASIVE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


[30845854061934]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-07-31

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10845854044322 - CONMED2024-03-28 Pin, Blunt, 2.4mm
20845854031619 - SEQUENT2024-03-28 SEQUENT DISPOSABLE SUTURE CUTTER
40845854061313 - PLUMEPEN2024-03-28 PlumePen Pro Disposable Capture Port Tips 4 in (10.16 cm)
40845854061337 - PLUMEPEN2024-03-28 PlumePen Pro Disposable Capture Port Tips 6 in (15.24 cm)
20653405012006 - EXCEL2024-03-27 EXCEL 10FT (3.05M) INSUFFLATION TUBING SET WITH 0.1 MICRON FILTER
20653405012013 - EXCEL2024-03-27 EXCEL 10FT (3.05M) INSUFFLATION TUBING SET WITH 0.1 MICRON FILTER

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