PressureMate Compression Assist Device 130-0200-00

GUDID 10815614020057

The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure with PressureMate in much the same way that they would when applying manual pressure. PressureMate is comprised of a non-sterile, reusable handle and a sterile, disposable SuperComfort Disc (Model 5303 or 5305) to aid in the practice of manual compression. The Model 3200 is of 12 oz. weighted aluminum construction.

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, reusable

• Primary Device ID: 10815614020057
• NIH Device Record Key: 590baf4c-179e-4dd2-b223-72e5018da2fe
• Commercial Distribution Discontinuation: 2022-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PressureMate Compression Assist Device
• Version Model Number: 3200
• Catalog Number: 130-0200-00
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	10815614020057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090286

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-11-30
• Device Publish Date: 2016-09-24

Devices Manufactured by SEMLER TECHNOLOGIES, INC.

• 10815614021085 - mBrace 4280 Wrist Support: 2024-02-09 The mBrace Model 4280 is a wrist support device that extends the patient's wrist at a consistent 30°angle with a syringe clip t
• 10815614020187 - CompressAR Large Round Disc: 2023-07-04 The CompressAR Large Round Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compre
• 10815614020194 - CompressAR Large Comfort Disc: 2023-07-04 The CompressAR Large Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply comp
• 10815614020217 - CompressAR Jumbo Comfort Disc: 2023-07-04 The CompressAR Jumbo Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply comp
• 10815614020224 - CompressAR 3-FingerJack Disc: 2023-07-04 The CompressAR 3-FingerJack Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compr
• 10815614020231 - CompressAR Large SuperComfort Disc: 2023-07-04 The CompressAR Large SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply
• 10815614020248 - CompressAR Jumbo SuperComfort Disc: 2023-07-04 The CompressAR Jumbo SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply
• 10815614020255 - ClampEase Disc: 2023-07-04 The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.