Zephyr Vascular Compression Device 190-0100-10

GUDID 30815614020730

The Zephyr Vascular Compression Device Model 9100-10 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-10 provides the regular sized strap which is 9.8”/25cm long.

SEMLER TECHNOLOGIES, INC.

Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device Radial artery compression device
Primary Device ID30815614020730
NIH Device Record Key9589f393-6c85-4ad3-bfdd-6203471fa1ee
Commercial Distribution Discontinuation2023-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZephyr Vascular Compression Device
Version Model Number9100-10
Catalog Number190-0100-10
Company DUNS042075700
Company NameSEMLER TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815614020736 [Primary]
GS120815614020733 [Package]
Contains: 10815614020736
Package: Casse [50 Units]
Discontinued: 2023-06-30
Not in Commercial Distribution
GS130815614020730 [Package]
Contains: 10815614020736
Package: Bag [10 Units]
Discontinued: 2023-06-30
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-07-03
Device Publish Date2017-10-17

On-Brand Devices [Zephyr Vascular Compression Device]

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

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