Single-use Flexible Bronchoscope

GUDID 06972197481068

Hunan Vathin Medical Instrument Co., Ltd

Flexible video bronchoscope, single-use

• Primary Device ID: 06972197481068
• NIH Device Record Key: 824d0bc8-4132-4ad0-9916-4fe5b6ba7d38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Flexible Bronchoscope
• Version Model Number: BC-S1J00-L
• Company DUNS: 554484862
• Company Name: Hunan Vathin Medical Instrument 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	06972197481068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241612

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: 2024-12-31
• Device Publish Date: 2024-12-23

On-Brand Devices [Single-use Flexible Bronchoscope]

• 06972197483291: BC-S1J00
• 06972197483284: BC-S1H00
• 06972197482751: BC-S1H00-L
• 06972197482744: BC-S1E00-L
• 06972197481082: BC-S1E00
• 06972197481068: BC-S1J00-L