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Luer Elbow 7.6mm Port Kit

FDA UDI

Class III (US FDA UDI)

by Beyond Air, Inc.

Identity

Trade Name
Luer Elbow 7.6mm Port Kit FDA UDI
Generic Name
Nitric oxide delivery unit, system-based FDA UDI
Device Name
The Luer elbow is a component to the gas sampling port which fits on a breathing circuit. FDA UDI
Model / Reference
90016 FDA UDI
Description
The Luer elbow is a component to the gas sampling port which fits on a breathing circuit. FDA UDI

Identifiers

Primary DI / UDI-DI
B882900160 FDA UDI
PMA Number
P200044 FDA UDI
FDA Product Code
QTB FDA UDI
GMDN Term
Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class
Class III 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
MRI Safety
MR Unsafe FDA UDI

Category: Nitric oxide delivery unit, system-based

Luer Elbow 7.6mm Port Kit by Beyond Air, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

P200044 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beyond Air, Inc.

Sources (1)

  • FDA UDI 460a0a0c-5439-41f8-b83e-c9ef5b70ccae 35 fields · synced Jun 8, 2026