Clevemed

GUDID 07290012186486

S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD

Polysomnography analyser

• Primary Device ID: 07290012186486
• NIH Device Record Key: 1fd589f3-dc2e-47d7-b69a-7b037666ef99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clevemed
• Version Model Number: 9101S-CL
• 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: false
• 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	07290012186486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042253

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 [Clevemed]

• 07290013818881: 9103-CL
• 07290013817686: 501-0261-5
• 07290013817679: 501-0261-4
• 07290013817662: 501-0261-3
• 07290013817655: 501-0261-2
• 07290013817648: 501-0261-1
• 07290012186660: 9101-CL
• 07290012186653: 9102-CL
• 07290012186493: 9102S-CL
• 07290012186486: 9101S-CL