ClampEase P-Series Disc 150-2031-70

GUDID 30815614020358

The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with a BALL attach.

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use

• Primary Device ID: 30815614020358
• NIH Device Record Key: c85099ff-fc4f-471a-8d12-f65e18cf8af3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClampEase P-Series Disc
• Version Model Number: P-700
• Catalog Number: 150-2031-70
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020354 [Primary]
GS1	20815614020351 [Package]; Contains: 10815614020354; Package: Bag [25 Units]; In Commercial Distribution
GS1	30815614020358 [Package]; Contains: 20815614020351; Package: Case [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863427

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-04
• Device Publish Date: 2016-09-24

On-Brand Devices [ClampEase P-Series Disc]

• 20815614021044: The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with
• 30815614020358: The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with