Whisper Soft

GUDID 10841470107892

ENGINEERED MEDICAL SYSTEMS INC

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 10841470107892
• NIH Device Record Key: 536a4e66-78cc-448f-b9e6-dbf08220f976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Whisper Soft
• Version Model Number: CS9410
• 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

Customer Support Contacts

• Phone: 317-246-5500
• Email: info@engmedsys.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470107895 [Primary]
GS1	10841470107892 [Package]; Contains: 00841470107895; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972605

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: 2017-02-24

On-Brand Devices [Whisper Soft]

• 10841470107885: CS9411
• 10841470107915: CS9408
• 10841470107908: CS9409
• 10841470107892: CS9410
• 10841470107830: CS9415
• 10841470107823: CS9414
• 10841470107816: CS9413
• 10841470107809: CS9412