Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- Respiratory oxygen therapy system FDA UDI
- Device Name
- BC173 Bubble CPAP System FDA UDI
- Model / Reference
- BC173-10 FDA UDI
- Description
- BC173 Bubble CPAP System FDA UDI
Identifiers
- Catalog Number
- BC173-10 FDA UDI
- Primary DI / UDI-DI
- 09420012424518 FDA UDI
- 510(k) Number
- K100011 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Respiratory oxygen therapy system 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
Yes
FDA UDI
Category: Respiratory oxygen therapy system
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen therapy system.
- 02-RESQ — Pulmodyne Inc. · Class II
- 02-RESQ — Pulmodyne Inc. · Class II
- GO-PAP — Pulmodyne Inc. · Class II
- O2-RESQ — Pulmodyne Inc. · Class II
- HI-OXYGEN MASK ADULT W/O VALVE, WITH 7FT TUBE, SINGLE PACKING — BESMED HEALTH BUSINESS CORP. · Class I
- O2-MAX — Pulmodyne Inc. · Class II
- Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
- AincA — Anesthesia Associates, Inc. · Class II
Cleared under the same submission
K100011 also covers:
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
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 |
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Manufacturer
- Manufacturer
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI 51b45908-e845-4d0a-aefd-d7a3ab4d3687 37 fields · synced May 30, 2026