DEVICE: CVAC Aspiration System (00860005357703)

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Device Identifier (DI) Information
CVAC Aspiration System
CVAC70
In Commercial Distribution

Calyxo, Inc.
00860005357703
GS1

1
080269404 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47464 Intracorporeal lithotripsy suction system
An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. It typically consists of a pneumatically-powered pump that creates suction via the venturi mechanism, a vacuum gauge, vacuum control knob, a compressed air connector, tubing, a moisture filter, and possibly a microbial filter. The vacuum created by the pump is applied to the body through the tubing and an inserted probe, for the removal of the calculi in a stone catcher and the fluid in a collection container.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FED Endoscopic Access Overtube, Gastroenterology-Urology
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K200419 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
Catheter Working Length: 70 Centimeter
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Device Record Status
0528a3ea-1216-46f4-822f-9384e0cf2801
December 09, 2020
1
December 01, 2020
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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
20860005357707 2 00860005357703 In Commercial Distribution
30860005357704 3 00860005357703 In Commercial Distribution
40860005357701 4 00860005357703 In Commercial Distribution
10860005357700 5 00860005357703 In Commercial Distribution
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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