SNT Biotech

GUDID 06973471967629

3 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 pcs per box

Shenzhen Dakewe Bio-engineering Co., Ltd

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• Primary Device ID: 06973471967629
• NIH Device Record Key: 280ea7b2-b7c6-4b89-936b-97b775a924f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SNT Biotech
• Version Model Number: VN
• Company DUNS: 543029175
• Company Name: Shenzhen Dakewe Bio-engineering 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973471967629 [Primary]
GS1	16973471967626 [Package]; 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: 2023-09-25
• Device Publish Date: 2023-09-16

Devices Manufactured by Shenzhen Dakewe Bio-engineering Co., Ltd

• 26973471968781 - DTPM: 2024-06-17 3 mL of Inactivated Transport Medium in screw-cap tube, with swab
• 06973471968763 - DTPM: 2024-05-28 3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs and oropharyngeal swabs.
• 06973471968503 - BioSci™: 2024-02-09 1 mL of Inactivated Transport Medium . 100 tests per package.
• 06973471968510 - BioSci™: 2024-02-09 2 mL of Inactivated Transport Medium. 100 tests per package.
• 06973471968527 - BioSci™: 2024-02-09 3 mL of Inactivated Transport Medium. 100 tests per package.
• 06973471960705 - Biosci™: 2023-11-14 3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
• 06973471967629 - SNT Biotech: 2023-09-253 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 pcs per box
• 06973471967629 - SNT Biotech: 2023-09-25 3 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 pcs per box
• 06973471960927 - BioSci™: 2023-07-12 1 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 tests per package