DEVICE: Sun Medical Inc (B22687300000)

Device Identifier (DI) Information

Sun Medical Inc
8730000
In Commercial Distribution
8730000
SUN MEDICAL INC
B22687300000
HIBCC

1
095223103 *Terms of Use
Smoke Evacuator Circuit
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Surgical fluid/smoke waste management system suction unit A mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.
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FDA Product Code

[?]
Product Code Product Code Name
FYD Apparatus, Exhaust, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K911154 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2a2c8cfa-3d75-49cf-9ca8-cb808e2cb5f5
July 06, 2018
3
January 23, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
9033569000
Spolk@sunmedicalinc.com
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