FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925002630
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
GY5-PCH
Device description
Fluid Pouch Disposable (12/PK)
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HIGInsufflator, Hysteroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905706000GYN-1500 HYSTEROSCOPIC INUFFLATORCircon Acmi1991-02-28HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925002630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925002630008219250026308219250026300821925002630

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic insufflatorA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space in which to carry out an examination or surgical intervention. 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

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10
00821925013032EVONOS1302042018-09-10
00821925013155EVONOS1302432018-09-10
00821925013285EVONOS1301352018-09-07
00821925013292EVONOS1301362018-09-07
00821925013308EVONOS1301372018-09-07
00821925013315EVONOS1301382018-09-07
00821925013612EVONOS1303132018-09-10
00821925013629EVONOS1303162018-09-10
00821925013827EVONOS1303652018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506023348Asurys™BOSTON SCIENTIFIC CORPORATIONHIG2026-04-03
00191506047962Asurys™BOSTON SCIENTIFIC CORPORATIONHIG2026-04-03
00850006759835Aveta Tissue Catch with TubingMEDITRINA, INC.HIG2026-03-20
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedMinerva Surgical, Inc.HIG2026-02-13
03700111401099RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401105RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401112RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401129RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
03700111401136SLIDING RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401143SLIDING RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401150SLIDING RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401167SLIDING RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
00850033976335Symphion Operative Hysteroscopy System Prime ControllerMinerva Surgical, Inc.HIG2025-10-31
00850006759811Aveta Drape PumpMEDITRINA, INC.HIG2025-04-11
07613327626391ThermaClearSTRYKER CORPORATIONHIG2025-04-04
07613327626407ThermaClearSTRYKER CORPORATIONHIG2025-04-04
04048551377567NAKarl Storz GmbH & Co. KGHIG2025-03-27
25420045516110Fluent Pro Waste BagHologic, Inc.HIG2024-10-15
25420045516134Fluent Pro Tissue TrapHologic, Inc.HIG2024-10-15
15420045516144Fluent Pro Procedure KitHologic, Inc.HIG2024-10-15
00850006759699Aveta Waste Management AccessoryMEDITRINA, INC.HIG2024-10-14
00850006759736Aveta Waste Bag with Tissue CatchMEDITRINA, INC.HIG2024-10-14
00850033976243Symphion Fluid Deficit ReadoutMinerva Surgical, Inc.HIG2024-08-12
15420045516212Fluent Pro Fluid Management SystemHologic, Inc.HIG2024-08-06
04056702012861GYN-PumpW.O.M. World of Medicine GmbHHIG2024-06-28
04056702012878Fluid Monitoring UnitW.O.M. World of Medicine GmbHHIG2024-06-28
00850006759460Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759484Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759613Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26
00850006759477Aveta Smol Disposable Resecting Device, 2.9 mmMEDITRINA, INC.HIG2024-04-26