Zephyr Vascular Compression Device 190-0100-20

GUDID 30815614020747

The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-20 provides the large strap which 11.8”/30cm long.

SEMLER TECHNOLOGIES, INC.

Radial artery compression device

• Primary Device ID: 30815614020747
• NIH Device Record Key: 71719972-e597-4a26-a70f-4978845972fb
• Commercial Distribution Discontinuation: 2023-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zephyr Vascular Compression Device
• Version Model Number: 9100-20
• Catalog Number: 190-0100-20
• 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	10815614020743 [Primary]
GS1	20815614020740 [Package]; Contains: 10815614020743; Package: Case [50 Units]; Discontinued: 2023-06-30; Not in Commercial Distribution
GS1	30815614020747 [Package]; Contains: 10815614020743; Package: Bag [10 Units]; Discontinued: 2023-06-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151363

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: 5
• Public Version Date: 2023-07-03
• Device Publish Date: 2017-10-17

On-Brand Devices [Zephyr Vascular Compression Device]

• 20815614020429: The Zephyr Vascular Compression Device Model 9200-20 has two easily inflatable compression ballo
• 20815614020412: The Zephyr Vascular Compression Device Model 9200-10 has two easily inflatable compression ballo
• 20815614020405: The Zephyr Vascular Compression Device Model 9200-00 has two easily inflatable compression ballo
• 20815614020399: The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression
• 20815614020382: The Zephyr Vascular Compression Device Model 9100-10 has a single easily inflatable compression
• 20815614020375: The Zephyr Vascular Compression Device Model 9100-00 has a single easily inflatable compression
• 10815614020958: The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression
• 30815614020778: The Zephyr Vascular Compression Device Model 9200-20 has two easily inflatable compression ballo
• 30815614020761: The Zephyr Vascular Compression Device Model 9200-10 has two easily inflatable compression ballo
• 30815614020754: The Zephyr Vascular Compression Device Model 9200-00 has two easily inflatable compression ballo
• 30815614020747: The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression
• 30815614020730: The Zephyr Vascular Compression Device Model 9100-10 has a single easily inflatable compression
• 30815614020723: The Zephyr Vascular Compression Device Model 9100-00 has a single easily inflatable compression