CompressAR Large Comfort Disc 150-0187-06

GUDID 10815614020194

The CompressAR Large 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 5187 is a large, round disc with upturned edges (2" dia.).

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use

• Primary Device ID: 10815614020194
• NIH Device Record Key: c27401c0-23b7-44b4-b686-75d536399d4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR Large Comfort Disc
• Version Model Number: 5187
• Catalog Number: 150-0187-06
• 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	10815614020194 [Primary]
GS1	20815614020191 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	30815614020198 [Package]; Contains: 20815614020191; 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: 2023-07-04
• Device Publish Date: 2016-09-24

Devices Manufactured by SEMLER TECHNOLOGIES, INC.

• 10815614020002 - CompressAR Compass Hand-Held Vascular Compression Assist Device: 2024-10-16 The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfor
• 10815614020019 - ComfortPress Hand-Held Vascular Compression Assist Device: 2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
• 10815614020026 - ComfortPress Hand-Held Vascular Compression Assist Device: 2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
• 20815614020030 - ComfortPress Hand-Held Vascular Compression Assist Device: 2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
• 10815614020040 - ComfortPress Hand-Held Vascular Compression Assist Device: 2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
• 10815614020064 - PressureMate Compression Assist Device: 2024-10-16 The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying ext
• 30815614020075 - RadAR Vascular Compression Device: 2024-10-16 The RadAR Vascular Compression Device Model 4150 provides economical, safe hemostasis for your post-catheterization radial acces
• 20815614020085 - RadAR Vascular Compression Device: 2024-10-16 The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial acces