FDA.reportPublic FDA data

RocaFlow - Irrigation and Warming System - Single Chamber

Primary DI
03700512956174
Brand
RocaFlow - Irrigation and Warming System - Single Chamber
Company
Promepla
Model
09-0053
Catalog number
MEN01US
Published
2017-11-09
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
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700512956174PackageGS11In Commercial Distribution
03700512955177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700512956174037005129561743700512956174
03700512955177037005129551773700512955177

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic irrigation/aspiration pumpA mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+37797984232customer@rocamed.eu

Regulatory Flags#

DUNS number
401020409
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
03700512905059Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512905073Irrigation TubeOSG03499ST35C8237522024-10-24
03700512905196Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512925064Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512925071Irrigation TubeOSG03499ST35C8237522024-10-24
03700512915263Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512901969Y-CLIC ADAPTER09-0197ROMYCLICST2282018-08-20
03700512963592BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmROUS1235STROUS1235ST2016-10-03
03700512963608BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmROUS1045STROUS1045ST2016-10-03
03700512963615BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmROUS1245STROUS1245ST2016-10-03
03700512965589RocaFlex Access Sheath & Dilation Catheter 10/12x35cmAS101235AS1012352016-09-14
03700512965596RocaFlex Access Sheath & Dilation Catheter 12/14x35cmAS101245AS1012452016-09-14
03700512965602RocaFlex Access Sheath & Dilation Catheter 10/12x45cmAS121435AS1214352016-09-14
03700512965619RocaFlex Access Sheath & Dilation Catheter 12/14x45cmAS121445AS1214452016-09-14
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm09-0015ROUS1035ST2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm09-0016ROUS1235ST2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm09-0017ROUS1045ST2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm09-0018ROUS1245ST2017-11-09
03700512967453LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire09-0124ROJS9522ST2282018-08-20
03700512967460LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire09-0125ROJS9524ST2282018-08-20

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Primary DI, Brand, Company table
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08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
04953170465277AUXILIARY WATER TUBEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-12-05
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
00858276007977CO2 Source Tubing Filter OlympusMicro-tech UsaOCX2025-05-12
00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860390Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860307A/W Channel Cleaning Adapter + 4-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258603694-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258605813-Piece Valve KitMicro-tech UsaOCX2025-03-03
00858276007243Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
00858276007335Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10