Pressure dome - 30034

GUDID 07071977000082

Memscap AS

Pressure transducer dome, single-use
Primary Device ID07071977000082
NIH Device Record Key660bde2a-5cbe-423f-90bf-a228de969a84
Commercial Distribution StatusIn Commercial Distribution
Brand NamePressure dome - 30034
Version Model Number1
Company DUNS515343676
Company NameMemscap AS
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107071977000082 [Primary]
GS117071977000089 [Package]
Package: [50 Units]
In Commercial Distribution
GS127071977000086 [Package]
Contains: 17071977000089
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRSTransducer, Blood-Pressure, Extravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-21

Devices Manufactured by Memscap AS

07071977000075 - SP 840 - 320212018-07-06
07071977000082 - Pressure dome - 300342018-07-06
07071977000082 - Pressure dome - 300342018-07-06

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