Identity
- Trade Name
- 15mm Gas Sample Adaptor Kit FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- 15mm Gas Sample Adaptor EUDAMED90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit. FDA UDI
- Model / Reference
- 90007 EUDAMEDFDA UDI
- Description
- 90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- +B8829000700 EUDAMEDB882900070 FDA UDI
- Basic UDI-DI
- ++B88290007KE EUDAMED
- PMA Number
- P200044 FDA UDI
- FDA Product Code
- QTB FDA UDI
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Medical Purpose
- Adaptors to connect the sample line into the inspiratory limb of 15mm ventilator breathing circuit tubing. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
15mm Gas Sample Adaptor by Beyond Air, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B88290007KE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Beyond Air, Inc.
- EUDAMED SRN
- US-PR-000047709
Sources (2)
- EUDAMED d9fcdd5f-5e9a-448f-b6fb-775798244be8 61 fields · synced Jul 20, 2026
- FDA UDI de628e2d-43f2-4d4b-8694-dbf02c7d274d 35 fields · synced May 30, 2026