FDA.reportPublic FDA data

Innovex

Primary DI
06970034210390
Brand
Innovex
Company
Shanghai AnQing Medical Instrument Co., Ltd
Model
BS41H-12EU
Published
2021-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211169000Bronchoscope SystemShanghai AnQing Medical Instrument Co., Ltd.2021-11-24EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970034210390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970034210390069700342103906970034210390

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useA sterile endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544581269
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
06970034211137InnovexEA1012025-06-10
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
06970034210406InnovexBS46H-17EU2021-12-09
06970034210413InnovexBS50H-20EU2021-12-09

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Primary DI, Brand, Company table
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