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
05051223022497
GS1

1
239403863 *Terms of Use
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).
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Device Characteristics

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

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Product Code Product Code Name
KZD Infusor, Pressure, For I.V. Bags
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FDA Premarket Submission

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

4edb97a7-2316-4c95-b182-a0d674b40387
March 29, 2018
2
October 18, 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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Yes
No
No
No
No CLOSE

Customer Contact

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+441923839333
mail@purplesurgical.com
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