Disposable Bronchial Cytology Brush

GUDID 00813353010363

Disposable Bronchial Cytology Brush 3.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Length

Telemed Systems

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 00813353010363
• NIH Device Record Key: e6517f5e-5a34-447a-ad43-dfbe431f21dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Bronchial Cytology Brush
• Version Model Number: 3104
• Company DUNS: 017939239
• Company Name: Telemed Systems
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813353010363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901436

FDA Product Code

• FDX: Endoscopic Cytology Brush

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: 2023-09-01
• Device Publish Date: 2023-08-24

On-Brand Devices [Disposable Bronchial Cytology Brush]

• 00813353010363: Disposable Bronchial Cytology Brush 3.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Lengt
• 00813353010356: Disposable Bronchial Cytology Brush 2.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Lengt