Seal Rite Mask

GUDID 04719872101208

Seal Rite Mask

ENTER MEDICAL CORPORATION

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 04719872101208
• NIH Device Record Key: 3fdcd345-8ef0-4b14-8607-b6af7f81ec5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seal Rite Mask
• Version Model Number: 120
• Company DUNS: 658833116
• Company Name: ENTER MEDICAL CORPORATION
• 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: 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	04719872101208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152521

FDA Product Code

• CBP: Valve, Non-Rebreathing

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: 2023-10-27
• Device Publish Date: 2023-10-19

Devices Manufactured by ENTER MEDICAL CORPORATION

• 04719872100607 - RESERVOIR: 2023-10-27 RESERVOIR
• 04719872101208 - Seal Rite Mask: 2023-10-27Seal Rite Mask
• 04719872101208 - Seal Rite Mask: 2023-10-27 Seal Rite Mask
• 04719872102021 - Catheter Mount: 2023-10-27 Catheter Mount
• 04719872103028 - Bubble Humidifier: 2023-10-27 Bubble Humidifier
• 04719872104414 - Nasal Cannula: 2023-10-27 Nasal Cannula
• 04719872104568 - reusable resuscitator: 2023-10-27 reusable resuscitator
• 04719872109631 - Disposable Resuscitator: 2023-10-27 Disposable Resuscitator
• 04719872109853 - Anaesthetic Face Mask: 2023-10-27 Anaesthetic Face Mask