Breathing Circuit

GUDID 04719872109501

Breathing Circuit

ENTER MEDICAL CORPORATION

Ventilator breathing circuit, single-use

• Primary Device ID: 04719872109501
• NIH Device Record Key: 44de4e8b-d244-4981-9a0f-0131ccb92777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breathing Circuit
• Version Model Number: ENT-2023
• Company DUNS: 658833116
• Company Name: ENTER MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	04719872109501 [Primary]

FDA Product Code

• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [Breathing Circuit]

• 04719872109532: Breathing Circuit
• 04719872109501: Breathing Circuit