ClampEase Disc 150-2001-24

GUDID 10815614020255

The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.

SEMLER TECHNOLOGIES, INC.

Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use Femoral artery compression system, manual, single-use
Primary Device ID10815614020255
NIH Device Record Key305831b7-776c-4f70-9b8a-15695d89e2c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameClampEase Disc
Version Model NumberFAPD-FB
Catalog Number150-2001-24
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
GS110815614020255 [Primary]
GS120815614020252 [Package]
Package: Bag [24 Units]
In Commercial Distribution
GS130815614020259 [Package]
Contains: 20815614020252
Package: Case [15 Units]
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 Number4
Public Version Date2023-07-04
Device Publish Date2016-09-24

On-Brand Devices [ClampEase Disc]

20815614021020The ClampEase FAPD-OT Disc is a femoral artery oval tunnel pressure disc with a TAPER attach.
20815614021037The ClampEase FAPD-RT Disc is a femoral artery round tunnel pressure disc with a TAPER attach.
10815614021016The ClampEase FAPD-RB Disc is a femoral artery round tunnel pressure disc with a BALL attach.
20815614021006The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.
10815614020309The ClampEase FAPD-RT Disc is a femoral artery round tunnel pressure disc with a TAPER attach.
10815614020293The ClampEase FAPD-OT Disc is a femoral artery oval tunnel pressure disc with a TAPER attach.
10815614020279The ClampEase FAPD-RB Disc is a femoral artery round tunnel pressure disc with a BALL attach.
10815614020255The ClampEase FAPD-FB Disc is a femoral artery flat tunnel pressure disc with a BALL attach.

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