NEONATAL DUAL HEATED WIRE B/C 1.6M (63") (KIT 2)

GUDID 05055788708537

FLEXICARE MEDICAL LIMITED

Ventilator breathing circuit, single-use

• Primary Device ID: 05055788708537
• NIH Device Record Key: f82b7219-f84d-4cb5-86e6-3c9780b654a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEONATAL DUAL HEATED WIRE B/C 1.6M (63") (KIT 2)
• Version Model Number: 038-33-202U
• 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	05055788708537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160540

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• 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