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NeoPAP Customer Trial Pack

FDA UDI

Class II (US FDA UDI)

by Circadiance

Identity

Trade Name
NeoPAP Customer Trial Pack FDA UDI
Generic Name
Neonatal CPAP unit FDA UDI
Device Name
Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3; Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3; Model # 1078537 – DI # B0361078537 – NeoPAP Bonnet M – Qty 3; Model # 1078538 – DI # B0361078538 – NeoPAP Bonnet L – Qty 2; Model # 1078539 – DI # B0361078539 – NeoPAP Bonnet XL – Qty 2; Model # 1110290 – DI # B0361110290 – NeoPAP Cannula XXS – Qty 2; Model # 1078611 – DI # B0361078611 – NeoPAP Cannula XS – Qty 2; Model # 1078612 – DI # B0361078612 – NeoPAP Cannula S – Qty 2; Model # 1078613 – DI # B0361078613 – NeoPAP Cannula M – Qty 2; Model # 1078614 – DI # B0361078614 – NeoPAP Cannula L – Qty 2; Model # 1078616 – DI # B0361078616 – NeoPAP Cannula XL – Qty 2; Model # 1078667 – DI # B0361078667 – NeoPAP Nasal Mask S – Qty 5; Model # 1078668 – DI # B0361078668 – NeoPAP Nasal Mask L – Qty 5; Model # 1078582 – DI # B0361078582 – NeoPAP Pressure Line & Sizing Kit – Qty 10 FDA UDI
Model / Reference
1078602 FDA UDI
Description
Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3; Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3; Model # 1078537 – DI # B0361078537 – NeoPAP Bonnet M – Qty 3; Model # 1078538 – DI # B0361078538 – NeoPAP Bonnet L – Qty 2; Model # 1078539 – DI # B0361078539 – NeoPAP Bonnet XL – Qty 2; Model # 1110290 – DI # B0361110290 – NeoPAP Cannula XXS – Qty 2; Model # 1078611 – DI # B0361078611 – NeoPAP Cannula XS – Qty 2; Model # 1078612 – DI # B0361078612 – NeoPAP Cannula S – Qty 2; Model # 1078613 – DI # B0361078613 – NeoPAP Cannula M – Qty 2; Model # 1078614 – DI # B0361078614 – NeoPAP Cannula L – Qty 2; Model # 1078616 – DI # B0361078616 – NeoPAP Cannula XL – Qty 2; Model # 1078667 – DI # B0361078667 – NeoPAP Nasal Mask S – Qty 5; Model # 1078668 – DI # B0361078668 – NeoPAP Nasal Mask L – Qty 5; Model # 1078582 – DI # B0361078582 – NeoPAP Pressure Line & Sizing Kit – Qty 10 FDA UDI

Identifiers

Catalog Number
1078602 FDA UDI
Primary DI / UDI-DI
B0361078602 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

No

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 Customer Trial Pack by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neonatal CPAP unit.

Cleared under the same submission

K103410 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Circadiance

Sources (1)

  • FDA UDI abf3d8ec-f7d6-40ec-96b6-cdfb8122e49c 36 fields · synced Jun 9, 2026