DEVICE: AER DEFENSE (30653405059084)

Device Identifier (DI) Information

AER DEFENSE
60-8080-120
Not in Commercial Distribution
60-8080-120
Conmed Corporation
30653405059084
GS1
November 19, 2020
1
071595540 *Terms of Use
AER DEFENSE SMOKE EVACUATOR SYSTEM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical plume evacuation system A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube
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FDA Product Code

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Product Code Product Code Name
FYD APPARATUS, EXHAUST, SURGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

26b36255-7a95-453e-9673-51c9337ec0fe
November 20, 2020
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
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