SealFlex

GUDID 20841470108186

ENGINEERED MEDICAL SYSTEMS INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 20841470108186
• NIH Device Record Key: 2d359cf8-4149-4c86-a537-8f9d373123b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SealFlex
• Version Model Number: 4-005520-00
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470108182 [Primary]
GS1	10841470108189 [Package]; Contains: 00841470108182; Package: [10 Units]; In Commercial Distribution
GS1	20841470108186 [Package]; Contains: 00841470108182; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023683

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-22

On-Brand Devices [SealFlex]

• 20841470108186: 4-005520-00
• 30841470108176: 4-005521-00