AMPHIRION DEEP

GUDID 08033477050454

CATH AMP030040002 AMPUS 03.00L40UL1200M2

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic
Primary Device ID08033477050454
NIH Device Record Key5602a60b-129e-4ed0-b11a-b6233d2a79c5
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAMPHIRION DEEP
Version Model NumberAMP030040002
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

Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter
Length40 Millimeter
Outer Diameter3 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108033477050454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-07-20
Device Publish Date2016-05-01

On-Brand Devices [AMPHIRION DEEP]

08033477050683CATH AMP040150152 AMPUS04.00L150UL1500M2
08033477050669CATH AMP040120152 AMPUS04.00L120UL1500M2
08033477050652CATH AMP040120002 AMPUS04.00L120UL1200M2
08033477050645CATH AMP040080152 AMPUS 04.00L80UL1500M2
08033477050638CATH AMP040080002 AMPUS 04.00L80UL1200M2
08033477050621CATH AMP040040152 AMPUS 04.00L40UL1500M2
08033477050607CATH AMP035150152 AMPUS03.50L150UL1500M2
08033477050584CATH AMP035120152 AMPUS03.50L120UL1500M2
08033477050560CATH AMP035080152 AMPUS 03.50L80UL1500M2
08033477050546CATH AMP035040152 AMPUS 03.50L40UL1500M2
08033477050522CATH AMP030150152 AMPUS03.00L150UL1500M2
08033477050508CATH AMP030120152 AMPUS03.00L120UL1500M2
08033477050485CATH AMP030080152 AMPUS 03.00L80UL1500M2
08033477050478CATH AMP030080002 AMPUS 03.00L80UL1200M2
08033477050461CATH AMP030040152 AMPUS 03.00L40UL1500M2
08033477050454CATH AMP030040002 AMPUS 03.00L40UL1200M2
08033477050447CATH AMP025150152 AMPUS02.50L150UL1500M2
08033477050423CATH AMP025120152 AMPUS02.50L120UL1500M2
08033477050416CATH AMP025120002 AMPUS02.50L120UL1200M2
08033477050409CATH AMP025080152 AMPUS 02.50L80UL1500M2
08033477050386CATH AMP025040152 AMPUS 02.50L40UL1500M2
08033477050362CATH AMP020150152 AMPUS02.00L150UL1500M2
08033477050348CATH AMP020120152 AMPUS02.00L120UL1500M2
08033477050331CATH AMP020120002 AMPUS02.00L120UL1200M2
08033477050324CATH AMP020080152 AMPUS 02.00L80UL1500M2
08033477050317CATH AMP020080002 AMPUS 02.00L80UL1200M2
08033477050300CATH AMP020040152 AMPUS 02.00L40UL1500M2
08033477050294CATH AMP020040002 AMPUS 02.00L40UL1200M2
08033477050287CATH AMP015020152 AMPUS 01.50L20UL1500M2
08033477050270CATH AMP015020002 AMPUS 01.50L20UL1200M2
08033477050263CATH AMP354210152 AMPUS3.5-4L210UL1500M2
08033477050249CATH AMP335210152 AMPUS3-3.5L210UL1500M2
08033477050225CATH AMP253210152 AMPUS2.5-3L210UL1500M2
08033477050201CATH AMP225210152 AMPUS2-2.5L210UL1500M2
08033477046167CATH AMP040150152 AMP US 04L150 UL1500
08033477046150CATH AMP040150002 AMP US 04L150 UL1200
08033477046143CATH AMP040120152 AMP US 04L120 UL1500
08033477046136CATH AMP040120002 AMP US 04L120 UL1200
08033477046129CATH AMP040080152 AMP US 04L80 UL1500
08033477046112CATH AMP040080002 AMP US 04L80 UL1200
08033477046105CATH AMP040040152 AMP US 04L40 UL1500
08033477046099CATH AMP040040002 AMP US 04L40 UL1200
08033477046082CATH AMP035150152 AMP US 03.5L150 UL1500
08033477046075CATH AMP035150002 AMP US 03.5L150 UL1200
08033477046068CATH AMP035120152 AMP US 03.5L120 UL1500
08033477046051CATH AMP035120002 AMP US 03.5L120 UL1200
08033477046044CATH AMP035080152 AMP US 03.5L80 UL1500
08033477046037CATH AMP035080002 AMP US 03.5L80 UL1200
08033477046020CATH AMP035040152 AMP US 03.5L40 UL1500
08033477046013CATH AMP035040002 AMP US 03.5L40 UL1200
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