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NOxBOXi System-I Test Kit

FDA UDI

Class II (US FDA UDI)

by Linde Gas & Equipment Inc.

Identity

Trade Name
NOxBOXi System-I Test Kit FDA UDI
Generic Name
Nitric oxide delivery unit, system-based FDA UDI
Device Name
NOxBOXi System-I Test Kit for use with the NOxBOXi nitric oxide delivery device. FDA UDI
Model / Reference
1 FDA UDI
Description
NOxBOXi System-I Test Kit for use with the NOxBOXi nitric oxide delivery device. FDA UDI

Identifiers

Primary DI / UDI-DI
00850046301001 FDA UDI
FDA Product Code
MRP FDA UDI
GMDN Term
Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Yes

FDA UDI

Category: Nitric oxide delivery unit, system-based

NOxBOXi System-I Test Kit by Linde Gas & Equipment Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitric oxide delivery unit, system-based.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Linde Gas & Equipment Inc.

Sources (1)

  • FDA UDI 5ac263b5-b24f-4f8d-b85d-4d31aa4e4827 34 fields · synced Sep 18, 2026