FDA.reportPublic FDA data

Tube set for suction (with 2 ports), single-use

Primary DI
04056702008833
Brand
Tube set for suction (with 2 ports), single-use
Company
W.O.M. World of Medicine GmbH
Model
OTFLWTBING
Published
2020-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)
HIGInsufflator, Hysteroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173489000GYN-Pump PH304W.O.M. World of Medicine GmbH2018-03-28HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056702008840PackageGS110In Commercial Distribution
04056702008833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056702008840040567020088404056702008840
04056702008833040567020088334056702008833

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Regulatory Flags#

DUNS number
316305242
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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

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