Infant Resuscitation Kit. T-Piece Circuit

GUDID 00854401006488

1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0

FLEXICARE MEDICAL LIMITED

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• Primary Device ID: 00854401006488
• NIH Device Record Key: 681596b5-842f-4724-bf03-5a343a495986
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Resuscitation Kit. T-Piece Circuit
• Version Model Number: NF-157-0U
• 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	00854401006488 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-12-11

On-Brand Devices [Infant Resuscitation Kit. T-Piece Circuit]

• 00854401006563: 1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 1
• 00854401006549: 1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0
• 00854401006525: 1.8m (70") with Anatomical Mask Size 1
• 00854401006488: 1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
• 00854401006457: 1.8m (70") Oxygen Line 2.1m (82") Anatomical Masks 0 + 1
• 00854401006440: 1.8m (70") with Anatomical Masks Sizes 0 + 1
• 00854401006433: 1.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1
• 00854401006426: 1.8m (70") with Round Masks Sizes 0 + 1
• 00854401006372: 1.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter
• 05055931119692: 1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 1
• 05055931119685: 1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0
• 05055931119678: 1.8m (70") with Anatomical Mask Size 1
• 05055931119654: 1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
• 05055931119647: NF-156U
• 05055931119630: 1.8m (70") with Anatomical Masks Sizes 0 + 1
• 05055931119623: 1.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1
• 05055931119616: 1.8m (70") with Round Masks Sizes 0 + 1
• 05055931119579: 1.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter