gudid
Primary ID: 90015
LungFit PH Verification Kit (UDI 90015)
Manufactured by Beyond Air, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LungFit PH Verification Kit - Primary ID 90015
Device Regulatory Overview
The LungFit PH Verification Kit (Model/Catalog Number: 90015) is a medical device manufactured by Beyond Air, Inc.. This product is indexed under FDA Product Code / Category Classification QTB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 90015
- Product Code / EMDN
- QTB
- Device Name
- The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).
- Database Sync Date
- 2026-08-09 09:06:21
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LungFit PH Verification Kit?
The registered manufacturer of record for LungFit PH Verification Kit is Beyond Air, Inc..
What is the Primary UDI-DI identifier for LungFit PH Verification Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 90015.
What classification code is assigned to this device?
This device is registered under product classification code QTB.
Similar Classification Devices (QTB)
Other Devices by Beyond Air, Inc.
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