ApneaStrip

GUDID 00857825005013

S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD

Respiratory apnoea monitoring system

• Primary Device ID: 00857825005013
• NIH Device Record Key: 7d2761bb-6ecc-460b-8829-7a7089af9cda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApneaStrip
• Version Model Number: 7200B
• Company DUNS: 600632715
• Company Name: S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
• 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: true
• Manufacturing Date: true
• 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	00857825005013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112822

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2016-09-20

On-Brand Devices [ApneaStrip]

• 00857825005013: 7200B
• 07290013818171: 7200A