DUALGUARD ADULT 10FT LINE WITH FEMALE LUER LOCK FI

GUDID 05055788714682

FLEXICARE MEDICAL LIMITED

Carbon-dioxide-sampling nasal oxygen cannula

• Primary Device ID: 05055788714682
• NIH Device Record Key: 9cbc77de-bd1b-4480-b52f-a9a94c28948d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALGUARD ADULT 10FT LINE WITH FEMALE LUER LOCK FI
• Version Model Number: 032-10-860U
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055788714682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140473

FDA Product Code

• MNK: Endoscopic Bite Block

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04

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