FDA.reportPublic FDA data

Dual chamber irrigation pump reusable

Primary DI
05051223022497
Brand
Dual chamber irrigation pump reusable
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS3871
Catalog number
PS3871
Device description
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
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZDInfusor, Pressure, For I.V. Bags

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZDInfusor, Pressure, For I.V. BagsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051223022497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051223022497050512230224975051223022497

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation solution pressure infusorA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441923839333mail@purplesurgical.com

Regulatory Flags#

DUNS number
239403863
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
55051223000612Hasson TrocarPS3210PS32102016-09-17
55051223000629Hasson TrocarPS3212PS32122016-09-17
55051223000636Secondary Trocar with gas portPS3307PS33072016-09-17
55051223000704Auto-shield trocar, ribbed cannulaPS3510PS35102016-09-17
35051223000717Auto-shield trocar, ribbed cannulaPS3512PS35122016-09-17
50551223000742Auto-shield trocar, ribbed cannulaPS3515PS35152016-09-17
35051223003374Auto Shield Trocar Ribbed, plus extra cannula PS3518PS35182016-09-17
50551223003873Secondary Trocar with gas portPS3305PS33052016-09-17
55051223003880Secondary Trocar without gas portPS3306PS33062016-09-17
55051223003897Secondary Trocar with Gas Port + Additional Cannula without Gas PortPS3355PS33552016-09-17
55051223003903Secondary trocar without Gas Port + Additional Cannula without Gas PortPS3356PS33562016-09-17
55051223003910Dilating tip trocar, ribbedPS3410PS34102016-09-17
55051223003927Dilating tip trocar, ribbedPS3415PS34152016-09-17
55051223003972Auto-shield trocar, ribbed PS3505PS35052016-09-17
55051223003996Universal cannulaPS3507PS35072016-09-17
50551223004009Universal cannulaPS3508 PS35082016-09-17
35051223004012Auto-shield trocar, ribbed cannulas plus extra cannulasPS3509PS35092016-09-17
35051223004029Auto-shield trocar, ribbed cannula plus additional cannulaPS3513PS35132016-09-17
35051223004036Auto-shield trocar, ribbed cannula plus extra cannulaPS3514PS35142016-09-17
55051223004856Ultimate Auto-shield trocar with ribbed cannulaPS3560ULTPS3560ULT2016-09-17

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Primary DI, Brand, Company table
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30889483642409Vital Signs™SUNMED, LLCKZD2025-07-31
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