Neoforce

GUDID 05055931106678

Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, Anatomical Mask Size 1

FLEXICARE MEDICAL LIMITED

Ventilator breathing circuit, single-use

• Primary Device ID: 05055931106678
• NIH Device Record Key: a62a3430-95b8-47f1-9425-1d41775ba395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neoforce
• Version Model Number: NF-187U
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055931106678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103833

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

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: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [Neoforce]

• 05055931117636: Infant Resuscitator T-Piece Circuit 1.9m (75") with Tethered Cap and Adjustable PEEP
• 05055931106715: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Round Mask Size 1
• 05055931106692: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Round Mask Size 0
• 05055931106678: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, Anatomical Mask Size 1
• 05055931106609: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, Anatomical Masks Sizes 0 + 1
• 05055931106579: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Round Mask Sizes 0+1
• 05055931106562: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, Round Masks Sizes 0 + 1
• 05055931106487: Infant Resuscitator T-Piece Circuit 1.9m (75") with Adjustable PEEP and Filter
• 05055931106517: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Catheter Adapter
• 05055931106661: Infant Resus Kit T-Piece Circuit 1.9m (75") with Filter, O2 Line 2.1m (82") Anatomical Mask Size
• 05055931106647: Infant Resus Kit T-Piece Circuit 1.9m(75)with Filter,O2 Line 2.1m(82) Anatomical Masks Size0
• 05055931106616: Infant Resus Kit T-Piece Circuit1.9m (75) with Filter,O2 Line2.1,(82) Anatomical Maks0+1