AccessGUDID - DEVICE: Luer Elbow 7.6mm Port Kit (B882900160)

GUDID

Device Identifier (DI) Information

Brand Name: Luer Elbow 7.6mm Port Kit
Version or Model: 90016
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beyond Air, Inc.

Primary DI Number: B882900160
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080243711 *Terms of Use

Device Description: The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37266	Nitric oxide delivery unit, system-based	A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTB	Nitric Oxide Generator And Delivery System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200044	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 460a0a0c-5439-41f8-b83e-c9ef5b70ccae
Public Version Date: February 14, 2025
Public Version Number: 2
DI Record Publish Date: August 04, 2022