FDA.reportPublic FDA data

Innovex

Primary DI
06970034211137
Brand
Innovex
Company
Shanghai AnQing Medical Instrument Co., Ltd
Model
EA101
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970034211137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970034211137069700342111376970034211137

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544581269
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970034211168InnovexUS38G-20-EU2025-12-08
06970034211175InnovexUS38G-20-US2025-12-08
06970034211182InnovexUS33G-17-EU2025-12-08
06970034211199InnovexUS33G-17-US2025-12-08
06970034211205InnovexUS27G-12-EU2025-12-08
06970034211212InnovexUS27G-12-US2025-12-08
06970034210222InnovexUS27F-12-EU2025-05-07
06970034210239InnovexUS27F-12-US2025-05-07
06970034210550InnovexCS50H-20EU2023-11-07
06970034210567InnovexCS50H-20US2023-11-07
06970034210512InnovexCY50H-20EU2023-06-15
06970034210536InnovexCY50H-20US2023-06-15
06970034210628InnovexUS31E-12-EU2022-10-21
06970034210635InnovexUS31E-12-US2022-10-21
06970034210383InnovexUS31D-12-EU2022-09-05
06970034210611InnovexUS31D-12-US2022-09-05
06970034210369InnovexEOS-H-012021-12-09
06970034210390InnovexBS41H-12EU2021-12-09
06970034210406InnovexBS46H-17EU2021-12-09
06970034210413InnovexBS50H-20EU2021-12-09

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