← Back to catalogue

NIPRO AQUALiner™

FDA UDI

Class II (US FDA UDI)

by Nipro Medical Corporation

Identity

Trade Name
NIPRO AQUALiner™ FDA UDI
Generic Name
Coronary artery guidewire extension FDA UDI
Device Name
SUPER ELASTIC HYDROPHILIC Ni-Ti ALLOY GUIDEWIRE FDA UDI
Model / Reference
ALS+35150AR FDA UDI
Description
SUPER ELASTIC HYDROPHILIC Ni-Ti ALLOY GUIDEWIRE FDA UDI

Identifiers

Primary DI / UDI-DI
00383790006057 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Coronary artery guidewire extension FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 150 Centimeter FDA UDI
Outer Diameter — 0.035 Inch FDA UDI

Category: Coronary artery guidewire extension

NIPRO AQUALiner™ by Nipro Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary artery guidewire extension.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (1)

  • FDA UDI 68b069f4-0985-4f6f-be22-ee6ffc22038f 35 fields · synced May 31, 2026