CompressAR Elliptical Comfort Disc 150-0197-06

GUDID 10815614020200

The CompressAR Oval (Elliptical) Comfort 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 5197 is an oval (ellliptical) disc with upturned edges (1.75” x 2.5").

SEMLER TECHNOLOGIES, INC.

Vascular compressor, external

• Primary Device ID: 10815614020200
• NIH Device Record Key: c1cb5fa9-3c61-42d2-be38-53ce1551cbe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR Elliptical Comfort Disc
• Version Model Number: 5197
• Catalog Number: 150-0197-06
• 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	10815614020200 [Primary]
GS1	20815614020207 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	30815614020204 [Package]; Contains: 20815614020207; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891000

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

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: 2022-01-17
• Device Publish Date: 2016-09-24

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