FDA.reportPublic FDA data

HIGH-FLOW TUBE SET

Primary DI
04056702001537
Brand
HIGH-FLOW TUBE SET
Company
W.O.M. World of Medicine GmbH
Model
0620050100
Published
2017-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OSVInsufflator, Endoscopic Vessel Harvesting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSVInsufflator, Endoscopic Vessel HarvestingObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170784000PNEUMOCLEARW.O.M. World of Medicine GmbH2017-05-15HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056702001537PackageGS110In Commercial Distribution
04056702001520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056702001537040567020015374056702001537
04056702001520040567020015204056702001520

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316305242
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056702012007Tube set for irrigation, single-useTS-P106-A2842302026-03-10
04056702012021Tube set for suction, 2-lines, single-useTS-P107-A2842312026-03-10
04056702012045Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2842322026-03-10
04056702012069Patient tube for irrigation, single-useTS-P508-A2842332026-03-10
04056702012083Tube set for vacuum, incl. filter, 30-day useTS-P501-C2842352026-03-10
04056702012106Tube set for suction, single-useTS-P102-H2842362026-03-10
04056702012120Tube set inflow 4-Spike adaptorTS-P502-A2842342026-03-10
04056702011970PUREVUE™ FMSPA1242842262026-03-10
04056702011987Autoclavable remote controlB022842272026-03-10
04056702011994Double pedal foot switchPZ3002842282026-03-10
04056702012014Tube set for irrigation, single-useTS-P106-A2026-03-10
04056702012038Tube set for suction, 2-lines, single-useTS-P107-A2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2026-03-10
04056702012076Patient tube for irrigation, single-useTS-P508-A2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useTS-P501-C2026-03-10
04056702012113Tube set for suction, single-useTS-P102-H2026-03-10
04056702012137Tube set inflow 4-Spike adaptorTS-P502-A2026-03-10
04056702012861GYN-PumpPH3042024-06-28
04056702012878Fluid Monitoring UnitPS3042024-06-28
04056702001544HEATED HUMIDIFIED TUBE SET06200503002017-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.OSV2025-02-27
00852588007151Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007168Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007175Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007182Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007199Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007205Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007212Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007236Insuflow PortLEXION MEDICAL, LLCOSV2020-11-05
00852588007229AP50/30 LEXION MEDICAL, LLCOSV2020-11-02
04056702008772Heating tube set for insufflation, single useW.O.M. World of Medicine GmbHOSV2020-11-01
04056702008796Tube set for insufflation, single-useW.O.M. World of Medicine GmbHOSV2020-11-01
04056702008895Insufflator 50LW.O.M. World of Medicine GmbHOSV2020-11-01
04056702005771Insufflator 50LW.O.M. World of Medicine GmbHOSV2018-03-27
04056702001483SMOKE EVACUATION HIGH-FLOW TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001506HEATED HUMIDIFIED SMOKE EVACUATION TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001520HIGH-FLOW TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001544HEATED HUMIDIFIED TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001568HEATED HIGH-FLOW TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001308PNEUMOCLEARW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001490SMOKE EVACUATION HIGH-FLOW TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001513HEATED HUMIDIFIED SMOKE EVACUATION TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001551HEATED HUMIDIFIED TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702001575HEATED HIGH-FLOW TUBE SETW.O.M. World of Medicine GmbHOSV2017-05-24
04056702003401PNEUMOCLEARW.O.M. World of Medicine GmbHOSV2017-05-24
04056702003432PNEUMOCLEARW.O.M. World of Medicine GmbHOSV2017-05-24
04056702003456PNEUMOCLEARW.O.M. World of Medicine GmbHOSV2017-05-24
04953170305009COMMUNICATION CABLE 0.7MOLYMPUS MEDICAL SYSTEMS CORP.OSV2016-09-21
04953170305023COMMUNICATION CABLE 1.8MOLYMPUS MEDICAL SYSTEMS CORP.OSV2016-09-21
04953170324147HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.OSV2016-09-21