FDA.reportPublic FDA data

Gimmi

Primary DI
04049047788584
Brand
Gimmi
Company
Gimmi GmbH
Model
CAM.1111.02
Device description
AlphaSMART Camera Head Full HD Autoclavable
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221591000Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light SourceSchoelly Fiberoptic GmbH2023-02-23GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047788584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047788584040490477885844049047788584

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags#

DUNS number
316152610
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047110682GimmiZ.0005.23Z.0005.232017-05-05
04049047111146GimmiZ.0530.60Z.0530.602017-05-05
04049047111474GimmiZ.0560.01Z.0560.012017-05-05
04049047111528GimmiZ.0560.60Z.0560.602017-05-05
04049047111535GimmiZ.0561.01Z.0561.012017-05-05
04049047111559GimmiZ.0561.60Z.0561.602017-05-05
04049047111580GimmiZ.1025.24Z.1025.242017-05-05
04049047111597GimmiZ.1025.60Z.1025.602017-05-05
04049047111801GimmiZ.1139.02Z.1139.022017-05-05
04049047111818GimmiZ.1139.60Z.1139.602017-05-05
04049047111832GimmiZ.1140.02Z.1140.022017-05-05
04049047111849GimmiZ.1140.60Z.1140.602017-05-05
04049047111863GimmiZ.1235.02Z.1235.022017-05-05
04049047111870GimmiZ.1235.60Z.1235.602017-05-05
04049047113973GimmiZ.3035.60Z.3035.602017-05-05
04049047114055GimmiZ.3235.01Z.3235.012017-05-05
04049047114086GimmiZ.3235.31Z.3235.312017-05-05
04049047114109GimmiZ.3235.60Z.3235.602017-05-05
04049047114604GimmiZ.4536.02Z.4536.022017-05-05
04049047114611GimmiZ.4536.60Z.4536.602017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826927713PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
17290016992158SOLO SCOPE Disposable ColonoscopeG.I. VIEW LTDFET2026-08-25
17290016992172SOLO SCOPE Video ControllerG.I. VIEW LTDFET2026-08-25
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.FET2026-07-22
04547410480269FUJIFILMFUJIFILM CORPORATIONFET2026-05-22
00840432200063CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
04049047788553GimmiGimmi GmbHFET2026-03-04
04049047788577GimmiGimmi GmbHFET2026-03-04
06971176282399EviewZhuhai Pusen Medical Technology Co, LtdFET2026-01-22
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FET2025-12-31
05391533810088ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
05391533810095ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.FET2025-11-21
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04961333255801INSPIRAHOYA CORPORATIONFET2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFET2025-06-20
04250480104200NASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONFET2025-05-31
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170445453OTV-S700 UPGRADE PACK 3DOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17