DEVICE: HEARTRAIL (04987350866059)

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Device Identifier (DI) Information

HEARTRAIL
40-5362
GC-U5AL020N
TERUMO CORPORATION
04987350866059
GS1
1
HEARTRAIL III Guiding Catheter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular guide-catheter, single-use A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 1.47 Millimeter
Pressure: 4826 KiloPascal
Device Size Text, specify: Shape name of distal shaft is AL2.0
Length: 100 Centimeter
Outer Diameter: 1.75 Millimeter
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Device Status

In Commercial Distribution
September 09, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54987350866054 5 04987350866059 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)283-7866
tmccustomer.admin@terumomedical.com
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