HEATED HIGH-FLOW TUBE SET

GUDID 04056702001575

W.O.M. World of Medicine GmbH

Endoscopic insufflation tubing set, single-use
Primary Device ID04056702001575
NIH Device Record Key6f812f03-741b-453e-8216-fe986e082ed9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEATED HIGH-FLOW TUBE SET
Version Model Number0620050200
Company DUNS316305242
Company NameW.O.M. World of Medicine GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056702001568 [Primary]
GS104056702001575 [Package]
Contains: 04056702001568
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSVInsufflator, Endoscopic Vessel Harvesting

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-24

Devices Manufactured by W.O.M. World of Medicine GmbH

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04056702012878 - Fluid Monitoring Unit2024-07-08
04056702008789 - Heating tube set for insufflation, single use2020-11-09
04056702008802 - Tube set for insufflation, single-use2020-11-09
04056702008826 - Tube set for suction, single-use2020-11-09
04056702008840 - Tube set for suction (with 2 ports), single-use2020-11-09
04056702008864 - Tube set for irrigation, single-use2020-11-09
04056702008888 - Tube set for vacuum incl. filter, 30-day use2020-11-09
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