Pulmonary Wedge Pressure Catheter

GUDID 20613994733652

ACCSY 150075 PULM WEDGE PRESS MONITOR5PK

MEDTRONIC, INC.

Pulmonary artery catheter, standard
Primary Device ID20613994733652
NIH Device Record Key587dee07-d4ff-41a1-9000-0f78e6d58710
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulmonary Wedge Pressure Catheter
Version Model Number150075
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French
Length110 Centimeter
Catheter Gauge7 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994733658 [Primary]
GS120613994733652 [Package]
Contains: 00613994733658
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-06-12

Devices Manufactured by MEDTRONIC, INC.

00763000764234 - NA2026-04-01 CUSTOM PACK CB11Z66R 1/4 LOOP
00763000764241 - NA2026-04-01 CUSTOM PACK CB11Z68R CDI PACK
00763000764319 - NA2026-04-01 CUSTOM PACK HY2G71R9 ST. AGNES PK
00763000764951 - NA2026-04-01 CUSTOM PACK BB12A73R AV LOOP
00763000770419 - NA2026-04-01 CUSTOM PACK 11Z79R1 VALVE SK LN
00763000770433 - NA2026-04-01 CUSTOM PACK BB12B18R HIIT FUS
00763000774127 - NA2026-04-01 CUSTOM PACK BB11U49R3 ADULT QUANTUM
00763000791421 - NA2026-04-01 CUSTOM PACK BB11Y57R5 HEART LUNG

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.