N/A

GUDID 06950940801875

Shenzhen Osto Technology Co.,Ltd.

Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control Respiratory syncytial virus (RSV) immunoglobulin G (IgG)/IgM antibody IVD, control

• Primary Device ID: 06950940801875
• NIH Device Record Key: 2f9531c0-5313-42cd-a0e9-ecc4c521c624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: AST-300L
• Company DUNS: 528161684
• Company Name: Shenzhen Osto Technology Co.,Ltd.
• Device Count: 351
• 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950940801868 [Primary]
GS1	06950940801875 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190783

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [N/A]

• 06950940801646: AST-905D
• 06950940801639: AST-905B
• 06950940801899: AST-2012A
• 06950940801875: AST-300L
• 06950940801936: AST-603