Single-use Bronchoscope

GUDID 06970462546061

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video bronchoscope, single-use

• Primary Device ID: 06970462546061
• NIH Device Record Key: 3b82c1d3-0467-4820-b908-0a533b7e47dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Bronchoscope
• Version Model Number: BR-M58
• Company DUNS: 403655303
• Company Name: Shenzhen HugeMed Medical Technical Development Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970462546061 [Primary]
GS1	26970462546065 [Package]; Package: CASE [10 Units]; Discontinued: 2024-06-14; Not in Commercial Distribution
GS1	36970462546062 [Package]; Package: CASE [5 Units]; Discontinued: 2024-06-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222910

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-21
• Device Publish Date: 2023-09-13

On-Brand Devices [Single-use Bronchoscope]

• 06970462546184: BR-M40H
• 06970462546177: BR-M52H
• 06970462546160: BR-M58H
• 06970462546153: BR-M25
• 06970462546115: BR-M22
• 06970462546108: BR-M32
• 06970462546092: BR-M40
• 06970462546085: BR-M50
• 06970462546078: BR-M52
• 06970462546061: BR-M58