NEBULIZER BOTTLE DISPOSABLE 6CC +1 more model
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Disposable Nebulizer Bottle, OD: 18mm EUDAMEDNEBULIZER BOTTLE DISPOSABLE 6CC; OD:18mm FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- Disposable Nebulizer, OD: 18mm EUDAMED
- Model / Reference
- NB-31100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770311005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04716770311005 EUDAMED
- 510(k) Number
- K091272 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
- GMDN Term
- Nebulizing system delivery set, reusable FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nebulizing system delivery set, reusable
NEBULIZER BOTTLE DISPOSABLE 6CC +1 more model by Besmed Health Business Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 2 models
Similar devices
Also classified as Nebulizing system delivery set, reusable.
- Omron Nosepiece for Nebulizer — Omron Healthcare, Inc. · Class II
- Nasoneb® — MONAGHAN MEDICAL CORP. · Class I
- Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Schuco — Allied Medical LLC · Class II
- Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
- VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
- Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
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: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
- Nebu-Life — CUTTING EDGE HC BRANDS LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
Sources (2)
- FDA UDI 4bff67c9-1d0e-41dc-93c4-8cf6864e9cb2 33 fields · synced Jun 19, 2026
- EUDAMED 8fdc7c2e-85e5-4742-9401-1af593c64356 61 fields · synced Jun 19, 2026