Zephyr Vascular Compression Device

Basic Information

• Brand Name: Zephyr Vascular Compression Device
• Primary DI: 10815614020767
• Version / Model: 9200-10
• Catalog Number: 190-0200-10
• Company Name: SEMLER TECHNOLOGIES, INC.
• Labeler DUNS: 042075700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-17
• Public Version: 5
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: bf842030-9e21-4d12-9940-b586d0d8cf3f
• Distribution End Date: 2023-06-30

Device Description

The Zephyr Vascular Compression Device Model 9200-10 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 9200-10 provides the regular strap which is 9.8”/25cm long.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58704	Radial artery compression device	A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30815614020761	GS1	Bag	10	Not in Commercial Distribution	2023-06-30
Primary	10815614020767	GS1
Package	20815614020764	GS1	Case	50	Not in Commercial Distribution	2023-06-30

Premarket Submissions

Submission Number	Supplement Number
K151363	000