SNT Biotech 6991311

GUDID 06973471969852

3 mL of Transport Medium in screw-cap tube, with minitip flocking swab

Shenzhen Dakewe Bio-engineering Co., Ltd

General specimen collection kit IVD, clinical

• Primary Device ID: 06973471969852
• NIH Device Record Key: c149dfaa-f78b-4965-8933-427c1f1f57a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SNT Biotech
• Version Model Number: VN
• Catalog Number: 6991311
• Company DUNS: 543029175
• Company Name: Shenzhen Dakewe Bio-engineering Co., Ltd
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973471967629 [Previous]
GS1	06973471969852 [Unit of Use]
GS1	16973471969859 [Primary]
GS1	26973471969856 [Package]; Contains: 16973471969859; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230035

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-24
• Device Publish Date: 2024-06-14

On-Brand Devices [SNT Biotech]

• 06973471967629: 3 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 pcs per box
• 26973471969863: Oropharyngeal swab.
• 06973471969852: 3 mL of Transport Medium in screw-cap tube, with minitip flocking swab