Identity
- Trade Name
- 22M-6mm Connector - Multipack FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- 80011 is a multipack of 20 oxygen stem connectors (off-the-shelf). - 1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The component is part of the LungFit PH verification kit. FDA UDI
- Model / Reference
- 80011 FDA UDI
- Description
- 80011 is a multipack of 20 oxygen stem connectors (off-the-shelf). - 1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The component is part of the LungFit PH verification kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B882800111 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
MR Unsafe FDA UDI
Category: Nitric oxide delivery unit, system-based
22M-6mm Connector - Multipack by Beyond Air, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Beyond Air, Inc.
Sources (1)
- FDA UDI 454d4dc8-b834-4c61-8533-0b694e5bb7a9 34 fields · synced May 31, 2026