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Zephyr Vascular Compression Device

FDA UDI

Class II (US FDA UDI)

by Semler Technologies, Inc.

Identity

Trade Name
Zephyr Vascular Compression Device FDA UDI
Generic Name
Radial artery compression device FDA UDI
Device Name
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. FDA UDI
Model / Reference
9200-00 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
190-0200-00 FDA UDI
Primary DI / UDI-DI
10815614020408 FDA UDI
510(k) Number
K151363 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Radial artery compression device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Zephyr Vascular Compression Device by Semler Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151363 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Semler Technologies, Inc.

Sources (1)

  • FDA UDI b5addc13-0075-490a-916a-e4f841ab19c1 36 fields · synced May 30, 2026