Single-use Bronchoscope

GUDID 26970462546737

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video bronchoscope, single-use
Primary Device ID26970462546737
NIH Device Record Key2acb0785-5775-4e89-9bc6-cf785b7d6762
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-use Bronchoscope
Version Model NumberBR-M30
Company DUNS403655303
Company NameShenzhen HugeMed Medical Technical Development Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970462546733 [Primary]
GS126970462546737 [Package]
Contains: 06970462546733
Package: CASE [10 Units]
Discontinued: 2025-05-08
Not in Commercial Distribution
GS136970462546734 [Package]
Contains: 06970462546733
Package: CASE [5 Units]
Discontinued: 2025-05-08
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-16
Device Publish Date2025-05-08

On-Brand Devices [Single-use Bronchoscope]

06970462546184BR-M40H
06970462546177BR-M52H
06970462546160BR-M58H
06970462546153BR-M25
06970462546115BR-M22
06970462546108BR-M32
06970462546092BR-M40
06970462546085BR-M50
06970462546078BR-M52
06970462546061BR-M58
26970462546737BR-M30
26970462546720BR-M42

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