Identity
- Trade Name
- Bleep Halos FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Model / Reference
- 100590 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003157115 FDA UDI
- 510(k) Number
- K172335 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Home 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
Yes
FDA UDI
Category: Home CPAP unit
Bleep Halos by Bleep, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home CPAP unit.
- DreamStation — Respironics, Inc. · Class II
- REMstar System One 60 Series — Respironics, Inc. · Class II
- DreamStation — Respironics, Inc. · Class II
- AIRSENSE — RESMED PTY LTD · Class II
- Transcend — SOMNETICS INTERNATIONAL, INC · Class II
- DreamStation — Respironics, Inc. · Class II
- DreamStation — Respironics, Inc. · Class II
- REMstar System One 60 Series — Respironics, Inc. · Class II
Cleared under the same submission
K172335 also covers:
- 6’ gray standard CPAP tube — BLEEP, LLC
- Bleep Dreamway — BLEEP, LLC
- Bleep Dreamway — BLEEP, LLC
- Dreamports — BLEEP, LLC
- Dreamprep — BLEEP, LLC
- Dreamway — BLEEP, LLC
- Dreamway clinical — BLEEP, LLC
- Dreamway connector kit — BLEEP, LLC
- Durable CPCP slim tube - 6' — BLEEP, LLC
- Eclipse Magnetic Frame — BLEEP, LLC
- Eclipse Magnetic Port Replacement Pack — BLEEP, LLC
- Eclipse Starter Kit — BLEEP, LLC
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
- Bleep, Llc
Sources (1)
- FDA UDI 8f2e8f0b-ac84-4204-b89d-df7c42e3bd7e 34 fields · synced May 31, 2026