DEVICE: Dual chamber irrigation pump reusable (05051223022497)
Device Identifier (DI) Information
Dual chamber irrigation pump reusable
PS3871
In Commercial Distribution
PS3871
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3871
In Commercial Distribution
PS3871
PURPLE SURGICAL INTERNATIONAL LIMITED
The re-usable Irrigation pump is a pneumatically operated device that has been designed to apply a pre set controlled pressure to 500ml – 1000ml size bags of saline solution (not supplied), enabling precise delivery of irrigation fluid during laparoscopic procedures utilising one of the Purple Surgical Suction & Irrigation sets (PS3800, PS3801, PS3850ULT or, PS3851ULT).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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62377 | Irrigation solution pressure infusor |
A pneumatically-powered device designed to apply pressure to a surgical irrigation solution bag to increase the flow rate of fluid (e.g., saline) delivery. It is designed with a pressure chamber into which the bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure regulator to adjust irrigation flow and overpressure safety features.
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FDA Product Code
[?]Product Code | Product Code Name |
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KZD | Infusor, Pressure, For I.V. Bags |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4edb97a7-2316-4c95-b182-a0d674b40387
March 29, 2018
2
October 18, 2016
March 29, 2018
2
October 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441923839333
mail@purplesurgical.com
mail@purplesurgical.com