GUDID 00643169200999

DISPLAY BOX 66000 PRESSURE

MEDTRONIC, INC.

Patient monitoring system module, blood pressure, invasive
Primary Device ID00643169200999
NIH Device Record Keyb225de1d-0f8d-4549-a7a2-452306d3f086
Commercial Distribution StatusIn Commercial Distribution
Version Model Number66000
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 TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169200999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXSGAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS

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 Date2016-04-28

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00763000762391 - Amplatz Goose Neck™2024-11-04 SNARE GN2000 GOOSENECK SNARE V02
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00763000762414 - Amplatz Goose Neck™2024-11-04 SNARE GN2501 GOOSENECK SNARE V02
00763000762421 - Amplatz Goose Neck™2024-11-04 SNARE GN3000 GOOSENECK SNARE V02

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