ProVu Single Use Video Stylet with ET Tube Size 7.5

GUDID 05055788782537

FLEXICARE MEDICAL LIMITED

Artificial airway stylet, single-use

• Primary Device ID: 05055788782537
• NIH Device Record Key: 930ba6bc-88c4-488c-bcf7-2ced83f201a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVu Single Use Video Stylet with ET Tube Size 7.5
• Version Model Number: 038-990-075U
• Company DUNS: 504406273
• Company Name: FLEXICARE MEDICAL LIMITED
• 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	05055788782537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091591

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

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: 2020-03-04
• Device Publish Date: 2020-02-25

Devices Manufactured by FLEXICARE MEDICAL LIMITED

• 15055788722462 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 4: 2024-08-15
• 15055788722486 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 3: 2024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Miller 3
• 15055788722509 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 2: 2024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Miller 2
• 15055788722523 - BriteBlade Pro Evo Single-Use Fiber Optic Miller 1: 2024-08-15
• 15055788722561 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 4: 2024-08-15
• 15055788722585 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 2: 2024-08-15
• 15055788722608 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 1: 2024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Mac 1
• 15055788722622 - BriteBlade Pro Evo Single-Use Fiber Optic Mac 1: 2024-08-15 BriteBlade Pro Evo Single-Use Fiber Optic Mac 1