Zephyr Vascular Compression Device 190-0200-00

GUDID 20815614020405

The Zephyr Vascular Compression Device Model 9200-00 has two easily inflatable compression balloons, one for the radial artery and one for the ulnar artery, that are easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9200-00 provides the small strap which is 8.2”/21cm long.

SEMLER TECHNOLOGIES, INC.

Radial artery compression device

• Primary Device ID: 20815614020405
• NIH Device Record Key: b5addc13-0075-490a-916a-e4f841ab19c1
• Commercial Distribution Discontinuation: 2020-09-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zephyr Vascular Compression Device
• Version Model Number: 9200-00
• Catalog Number: 190-0200-00
• 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: 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	10815614020408 [Primary]
GS1	20815614020405 [Package]; Contains: 10815614020408; Package: Case [50 Units]; Discontinued: 2020-09-28; Not in Commercial Distribution
GS1	30815614020402 [Package]; Contains: 10815614020408; Package: Bag [10 Units]; Discontinued: 2020-09-28; 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: 4
• Public Version Date: 2020-09-29
• Device Publish Date: 2016-09-24

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