FDA.report

NAVICROSS

Primary DI
54987350709221
Brand
NAVICROSS
Company
TERUMO CORPORATION
Model
NC35151
Catalog number
WS*NA35153H
Device description
NAVICROSS Support 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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54987350709221PackageGS15In Commercial Distribution
04987350709226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5498735070922154987350709221
04987350709226049873507092264987350709226

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
Device Size Text, specify0
Length150Centimeter
Outer Diameter1.39Millimeter
Pressure5171KiloPascal

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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