DEVICE: NA (04055207057100)

Device Identifier (DI) Information

NA
2207011
In Commercial Distribution
2207.011
Richard Wolf GmbH
04055207057100
GS1

1
315304071 *Terms of Use
SUCTION PUMP for US Litho 2271, with speed control for pressure setting between 0.1 and 0.6 bar, U: 100-230VAC/ 50/60Hz, Dim. (wxhxd): 320x120x225mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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

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Product Code Product Code Name
JCX APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c33e1367-f85b-49ae-ad36-070507f48269
March 29, 2018
2
July 21, 2017
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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)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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