FDA.reportPublic FDA data

NA

Primary DI
04055207012123
Brand
NA
Company
Richard Wolf GmbH
Model
2235103
Catalog number
2235103
Device description
SOFTWARE MODULE VIDEO WINDOW for INSUFFLATOR HIGHFLOW 45, for activation of the video window by DIALOG via CAN-BUS
Published
2017-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207012123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207012123040552070121234055207012123

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic insufflatorA mains electricity (AC-powered) device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization (e.g., prevent dew/mist accumulating at the lens) through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. This device may also be referred to as a gas distention system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
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
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
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304751404InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
16972304751555InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
10851885004587AIRSEALConmed CorporationHIF2026-03-21
00860012249954VereSeeFreyja Healthcare, LLCHIF2025-06-18
00860012249916VereSeeFreyja Healthcare, LLCHIF2025-06-16
G465100300AirSurgN InsufflatorSmartsurgn Inc.HIF2025-04-22
04953170467226INSUFFLATION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
04953170467233SUCTION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
05391536920142EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920159EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920913EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920944EVA15PALLIARE LIMITEDHIF2024-07-16
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
20845854045630AIRSEALConmed CorporationHIF2024-03-27
06973031299573Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299870Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299887InsufflatorGuangdong Optomedic Technologies, Inc.HIF2024-03-26
10886874120696NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
06971381251357InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
06971381251364InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
10845854045350CONMEDConmed CorporationHIF2023-12-04
10845854045398CONMEDConmed CorporationHIF2023-12-04
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpHIF2023-07-31
09420012433060Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
09420012433985Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
00850082007189Filter AssemblyARMM INC.HIF2023-06-08
00850082007196Insufflator Filter AssemblyARMM INC.HIF2023-06-08
00850082007837Insufflator Filter AssemblyARMM INC.HIF2023-06-08