PACIFIC XTREME

GUDID 08033477076041

CATH PCU050150130 PCU US 05 00L150UL1300

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic
Primary Device ID08033477076041
NIH Device Record Key40d48b69-7d4b-40c8-8552-d5d203d35a85
Commercial Distribution StatusIn Commercial Distribution
Brand NamePACIFIC XTREME
Version Model NumberPCU050150130
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

Device Dimensions

Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter
Length150 Millimeter
Outer Diameter5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.

Device Identifiers

Device Issuing AgencyDevice ID
GS108033477076041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-07-20
Device Publish Date2019-02-24

On-Brand Devices [PACIFIC XTREME]

08033477076102CATH PCU050300130 PCU US 05 00L300UL1300
08033477076096CATH PCU050300090 PCU US 05 00L300UL0900
08033477076089CATH PCU050250130 PCU US 05 00L250UL1300
08033477076072CATH PCU050250090 PCU US 05 00L250UL0900
08033477076065CATH PCU050200130 PCU US 05 00L200UL1300
08033477076058CATH PCU050200090 PCU US 05 00L200UL0900
08033477076041CATH PCU050150130 PCU US 05 00L150UL1300
08033477076034CATH PCU050150090 PCU US 05 00L150UL0900
08033477076027CATH PCU040300130 PCU US 04 00L300UL1300
08033477076010CATH PCU040300090 PCU US 04 00L300UL0900
08033477076003CATH PCU040250130 PCU US 04 00L250UL1300
08033477075990CATH PCU040250090 PCU US 04 00L250UL0900
08033477075983CATH PCU040200130 PCU US 04 00L200UL1300
08033477075976CATH PCU040200090 PCU US 04 00L200UL0900
08033477075969CATH PCU040150130 PCU US 04 00L150UL1300
08033477075952CATH PCU070250130 PCU US 07 00L250UL1300
08033477075945CATH PCU070250090 PCU US 07 00L250UL0900
08033477075938CATH PCU070200130 PCU US 07 00L200UL1300
08033477075921CATH PCU070200090 PCU US 07 00L200UL0900
08033477075914CATH PCU070150130 PCU US 07 00L150UL1300
08033477075907CATH PCU070150090 PCU US 07 00L150UL0900
08033477075891CATH PCU060300130 PCU US 06 00L300UL1300
08033477075884CATH PCU060300090 PCU US 06 00L300UL0900
08033477075877CATH PCU060250130 PCU US 06 00L250UL1300
08033477075860CATH PCU060250090 PCU US 06 00L250UL0900
08033477075853CATH PCU060200130 PCU US 06 00L200UL1300
08033477075846CATH PCU060200090 PCU US 06 00L200UL0900
08033477075839CATH PCU060150130 PCU US 06 00L150UL1300
08033477075594CATH PCU060150090 PCU US 06 00L150UL0900
08033477075587CATH PCU040150090 PCU US 04 00L150UL0900
08033477058504CATH PCU050300130 PCU US 05 00L300UL1300
08033477058498CATH PCU050300090 PCU US 05 00L300UL0900
08033477058481CATH PCU050250130 PCU US 05 00L250UL1300
08033477058474CATH PCU050250090 PCU US 05 00L250UL0900
08033477058467CATH PCU050200130 PCU US 05 00L200UL1300
08033477058450CATH PCU050200090 PCU US 05 00L200UL0900
08033477058443CATH PCU050150130 PCU US 05 00L150UL1300
08033477058436CATH PCU050150090 PCU US 05 00L150UL0900
08033477058429CATH PCU040300130 PCU US 04 00L300UL1300
08033477058412CATH PCU040300090 PCU US 04 00L300UL0900
08033477058405CATH PCU040250130 PCU US 04 00L250UL1300
08033477058399CATH PCU040250090 PCU US 04 00L250UL0900
08033477058382CATH PCU040200130 PCU US 04 00L200UL1300
08033477058375CATH PCU040200090 PCU US 04 00L200UL0900
08033477058368CATH PCU040150130 PCU US 04 00L150UL1300
08033477058351CATH PCU040150090 PCU US 04 00L150UL0900
08033477058344CATH PCU070250130 PCU US 07 00L250UL1300
08033477058337CATH PCU070250090 PCU US 07 00L250UL0900
08033477058320CATH PCU070200130 PCU US 07 00L200UL1300
08033477058313CATH PCU070200090 PCU US 07 00L200UL0900

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