FDA.report

Insufflation filter / tubing set with luer lock co

Primary DI
05051223004073
Brand
Insufflation filter / tubing set with luer lock co
Company
PURPLE SURGICAL INTERNATIONAL LIMITED
Model
PS3600
Catalog number
PS3600
Device description
The Insufflation filter / tubing set effectively prevents cross contamination between the patient & insufflator.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKCTubing/Tubing With Filter, Insufflation, Laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35051223004074PackageGS125In Commercial Distribution
05051223004073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3505122300407435051223004074
05051223004073050512230040735051223004073

GMDN Terms

TermDefinition
Microbial medical gas filter, sterile, single-useA sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia, and/or surgical intervention (e.g., insufflation); it has no additional non-filtering intended uses. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Sterilization Methods

Method

Contacts

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
true
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 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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