ClampEase P-Series Disc 150-2031-70a

GUDID 20815614021044

The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with a BALL attach.

SEMLER TECHNOLOGIES, INC.

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Primary Device ID20815614021044
NIH Device Record Keyf66cac07-3155-46b4-9b06-1621f927f6a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameClampEase P-Series Disc
Version Model NumberP-700
Catalog Number150-2031-70a
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
GS110815614021047 [Primary]
GS120815614021044 [Package]
Contains: 10815614021047
Package: Bag [25 Units]
In Commercial Distribution
GS130815614021041 [Package]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-09
Device Publish Date2022-09-01

On-Brand Devices [ClampEase P-Series Disc]

20815614021044The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with
30815614020358The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with

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