FDA.report

HEARTRAIL

Primary DI
54987350866313
Brand
HEARTRAIL
Company
TERUMO CORPORATION
Model
40-5347
Catalog number
GC-U5JR500N
Device description
HEARTRAIL III Guiding Catheter
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54987350866313PackageGS15In Commercial Distribution
04987350866318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5498735086631354987350866313
04987350866318049873508663184987350866318

GMDN Terms

TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), 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, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length100Centimeter
Lumen/Inner Diameter1.47Millimeter
Outer Diameter1.75Millimeter
Pressure4826KiloPascal

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
690543319
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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