Identity
- Trade Name
- NeoPAP Cannula - L FDA UDI
- Generic Name
- Neonatal CPAP unit FDA UDI
- Device Name
- NeoPAP Cannula - L FDA UDI
- Model / Reference
- 1078614 FDA UDI
- Description
- NeoPAP Cannula - L FDA UDI
Identifiers
- Catalog Number
- 1078614 FDA UDI
- Primary DI / UDI-DI
- B0361078614 FDA UDI
- 510(k) Number
- K103410 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Neonatal CPAP unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neonatal CPAP unit
NeoPAP Cannula - L by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal CPAP unit.
- NeoPAP Bonnet - M — Circadiance · Class II
- NeoPAP Device - US — Circadiance · Class II
- NeoPAP Mask - S — Circadiance · Class II
- NeoPAP Cannula - XS — Circadiance · Class II
- NeoPAP Bonnet - S — Circadiance · Class II
- NeoPAP Cannula - S — Circadiance · Class II
- NeoPAP Mask - L — Circadiance · Class II
- NeoPAP Delivery Circuit Adapter & Sizing Chart — Circadiance · Class II
Cleared under the same submission
K103410 also covers:
- NeoPAP Bonnet - L — Circadiance
- NeoPAP Bonnet - M — Circadiance
- NeoPAP Bonnet - S — Circadiance
- NeoPAP Bonnet - XL — Circadiance
- NeoPAP Bonnet - XS — Circadiance
- NeoPAP Cannula - M — Circadiance
- NeoPAP Cannula - S — Circadiance
- NeoPAP Cannula - XL — Circadiance
- NeoPAP Cannula - XS — Circadiance
- NeoPAP Cannula - XXS — Circadiance
- NeoPAP Customer Trial Pack — Circadiance
- NeoPAP Delivery Circuit Adapter & Sizing Chart — Circadiance
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Circadiance
Sources (1)
- FDA UDI 7fba2731-9c02-4ee5-a8c8-74be79ccde43 36 fields · synced Jun 9, 2026