FDA.reportPublic FDA data

Suction Irrigation System

Primary DI
00607915146498
Brand
Suction Irrigation System
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
C6001
Device description
Probe and Valve with dual bag tubing, 5mmx33cm
Published
2024-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHFSystem, Evacuator, Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHFSystem, Evacuator, FluidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915146495PackageGS11In Commercial Distribution
00607915146498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791514649510607915146495
00607915146498006079151464986079151464980607915146498

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9497138300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19
00607915146467Voyant Electrosurgical GeneratorEA0302026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009877801ClearwandMORRIS MEDICAL, INC.FHF2024-10-22
00860009877818ClearwandMORRIS MEDICAL, INC.FHF2024-10-22
00607915146504Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
03700512902102RocaFlow Laparoscopy TubingPromeplaFHF2020-08-27
03700512912101RocaFlow Endoscopy TubingPromeplaFHF2020-08-27
03700512902034Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512902041Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512902058Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512902065Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512902072Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512902089Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512922032Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512922049Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512922056Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512922063Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512922070Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512922087Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512901976Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
03700512921974Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
06939029815187SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
26939029815181SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
06939029815163MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
06939029815170MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815167MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815174MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
03700512901839Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512901860Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512921837Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512921868Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512901815Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spikePromeplaFHF2017-11-09