Zephyr Vascular Compression Device 190-0100-00

GUDID 20815614020375

The Zephyr Vascular Compression Device Model 9100-00 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-00 provides the small sized strap which is 8.2”/21cm long.

SEMLER TECHNOLOGIES, INC.

Radial artery compression device

• Primary Device ID: 20815614020375
• NIH Device Record Key: e8052e61-d003-4076-969b-c901098b1cef
• Commercial Distribution Discontinuation: 2020-09-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zephyr Vascular Compression Device
• Version Model Number: 9100-00
• Catalog Number: 190-0100-00
• 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	10815614020378 [Primary]
GS1	20815614020375 [Package]; Contains: 10815614020378; Package: Case [50 Units]; Discontinued: 2020-09-28; Not in Commercial Distribution
GS1	30815614020372 [Package]; Contains: 10815614020378; 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