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Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Device Name
- Adult Nebulizer Kits - Disposable - w/ Jet Nebulizer, Aerosol Mask, 7ft O2 Tubing - 50/case FDA UDI
- Model / Reference
- RES090 FDA UDI
- Description
- Adult Nebulizer Kits - Disposable - w/ Jet Nebulizer, Aerosol Mask, 7ft O2 Tubing - 50/case FDA UDI
Identifiers
- Catalog Number
- RES090 FDA UDI
- Primary DI / UDI-DI
- 00848530060787 FDA UDI
- 510(k) Number
- K091272 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
No
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: Aerosol face mask, rebreathing, single-use
Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol Mask by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Aerosol face mask, rebreathing, single-use.
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- System 22 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
Cleared under the same submission
K091272 also covers:
- JET NEBULIZER MASK , CHILD SET 20CC 7Ft OXYGEN TUBING (Universal connector one e — BESMED HEALTH BUSINESS CORP.
- JET NEBULIZER MASK(SWIVEL) , ADULT SET 7Ft OXYGEN TUBING, GOBAL:63-510A — BESMED HEALTH BUSINESS CORP.
- MINI JET NEBULIZER SET 6CC (Screw);OD:18mm W/7Ft OXYGEN TUBING — BESMED HEALTH BUSINESS CORP.
- MINI JET NEBULIZER SET 6CC/OD:18mm(W/O CORRUGATE TUBING) — BESMED HEALTH BUSINESS CORP.
- MINI JET NEBULIZER SET 8CC W/7Ft OXYGEN TUBING — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE DISPOSABLE 6CC; — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE DISPOSABLE 6CC; OD:18mm — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE DISPOSABLE 6CC; OD:22mm — BESMED HEALTH BUSINESS CORP.
- NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm, ONE PIECE (SET OF 5) — BESMED HEALTH BUSINESS CORP.
- NEBULIZER SET 20CC W/T-PIECE, MOUTH PIECE — BESMED HEALTH BUSINESS CORP.
- Nebu-Life — CUTTING EDGE HC BRANDS LLC
- Nebu-Life — CUTTING EDGE HC BRANDS 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 |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI e3502f4c-979e-4752-a326-bf35d7d51e80 37 fields · synced Jun 6, 2026