GUDID 00643169858879

TRANSDUCER 95184-003 BIO-PROBE TX-50 FA

MEDTRONIC, INC.

Blood flowmeter transducer, non-indwelling Blood flowmeter transducer, non-indwelling
Primary Device ID00643169858879
NIH Device Record Keyffd813a8-225c-450f-a202-9935e66928a7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number95184-003
Company DUNS006261481
Company NameMEDTRONIC, 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169858879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-13

Devices Manufactured by MEDTRONIC, INC.

00763000443214 - NA2024-05-27 CABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR
00763000465728 - NA2024-05-27 CABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR
00763000723293 - ClosureRFS™2024-05-27 STYLET RFS2-6-12 CLOSUREFAST
00763000849078 - Vanta™ AdaptiveStim™2024-05-27 INS 977006 VANTA US EMAN CARDIO
00763000852887 - Injex®2024-05-27 ACCESS 97791 INJEX BUMPY ANCHOR EMAN
00763000852894 - Injex®2024-05-27 ACCESS 97792 INJEX BI-WING ANCHOR EMAN
00763000905590 - Launcher™2024-05-27 CATHETER LA6SCR40K LA 6F 55CM SCR40
00763000905606 - Launcher™2024-05-27 CATHETER LA6MP1K LA 6F 55CM MP1

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