CompressAR StrongArm 3-FingerJack Stand 160-0000-06

GUDID 10815614020477

The CompressAR StrongArm 3-FingerJack Stand is used with a CompressAR 3-FingerJack Disc, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures. This catalog number is compatible with CompressAR 3-FingerJack Disc Model 5301.

Semler Technologies, Inc.

Femoral artery compression system, manual, reusable
Primary Device ID10815614020477
NIH Device Record Key0feb15c0-1034-49cb-aa8e-b1c10308d77f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompressAR StrongArm 3-FingerJack Stand
Version Model Number6000
Catalog Number160-0000-06
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815614020477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2024-10-16
Device Publish Date2016-09-24

Devices Manufactured by Semler Technologies, Inc.

10815614020002 - CompressAR Compass Hand-Held Vascular Compression Assist Device2024-10-16 The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfor
10815614020019 - ComfortPress Hand-Held Vascular Compression Assist Device2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
10815614020026 - ComfortPress Hand-Held Vascular Compression Assist Device2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
20815614020030 - ComfortPress Hand-Held Vascular Compression Assist Device2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
10815614020040 - ComfortPress Hand-Held Vascular Compression Assist Device2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
10815614020064 - PressureMate Compression Assist Device2024-10-16 The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying ext
30815614020075 - RadAR Vascular Compression Device2024-10-16 The RadAR Vascular Compression Device Model 4150 provides economical, safe hemostasis for your post-catheterization radial acces
20815614020085 - RadAR Vascular Compression Device2024-10-16 The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial acces

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.