CompressAR Large Round Disc 150-0123-06

GUDID 10815614020187

The CompressAR Large Round Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5123 is a large, round flat disc (2" dia.).

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use

• Primary Device ID: 10815614020187
• NIH Device Record Key: 06ebd276-c5f5-45a2-ad87-ffed22c72a28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR Large Round Disc
• Version Model Number: 5123
• Catalog Number: 150-0123-06
• 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	10815614020187 [Primary]
GS1	20815614020184 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	30815614020181 [Package]; Contains: 20815614020184; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831337

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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

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