AMPHIRION DEEP

GUDID 08033477050201

CATH AMP225210152 AMPUS2-2.5L210UL1500M2

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 08033477050201
• NIH Device Record Key: 00cc6573-f67d-4b08-aff2-3ff1d7260038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPHIRION DEEP
• Version Model Number: AMP225210152
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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, Specify: Between 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 Agency	Device ID
GS1	08033477050201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083919

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-20
• Device Publish Date: 2016-05-07

On-Brand Devices [AMPHIRION DEEP]

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