Identity
- Trade Name
- Flow-Safe Disposable CPAP System FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Model / Reference
- 10-57022 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043570227 FDA UDI
- 510(k) Number
- K090710 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5965 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CPAP/BPAP nasal mask, single-use
Flow-Safe Disposable CPAP System by Mercury Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP nasal mask, single-use.
- BiTrac Vented — Pulmodyne Inc. · Class II
- PN841 — Respironics, Inc. · Class II
- PN841 — Respironics, Inc. · Class II
- BiTrac HC — Pulmodyne Inc. · Class II
- FitStar Hospital Nasal Non Vented Mask, s/m — Sleepnet Corporation · Class II
- Whisper Soft — Engineered Medical Systems, LLC · Class II
- BiTrac — Pulmodyne Inc. · Class II
- BiTrac — Pulmodyne Inc. · Class II
Cleared under the same submission
K090710 also covers:
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, INC.
- Flow-Safe Disposable CPAP System — MERCURY ENTERPRISES, 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
- Mercury Enterprises, Inc.
Sources (1)
- FDA UDI 155fff6d-4002-450d-a96f-8f39c5964019 34 fields · synced Jun 8, 2026