Identity
- Trade Name
- Bentely the Bear Pediatric Nebulizer FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- Bentely the Bear Pediatric Nebulizer FDA UDI
- Model / Reference
- 240486 FDA UDI
- Description
- Bentely the Bear Pediatric Nebulizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372217005049 FDA UDI
- 510(k) Number
- K043238 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, reusable 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, reusable
Bentely the Bear Pediatric Nebulizer by Arise Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K043238 also covers:
- Captian Eagle Pediatric Nebulizer — ARISE MEDICAL LLC
- Sparky the Dog Pediatric Nebulizer — ARISE MEDICAL LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Shuco — Allied Medical LLC
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Dynarex My Resp-O2 Doggy Compressor Nebulizer — Dynarex Corp.
- My Doggy Compressor Nebulizer — Dynarex Corp.
- My Penguin Compressor Nebulizer — Dynarex Corp.
- My Resp-O2 Penguin Compressor Nebulizer — Dynarex Corp.
- Veridian — VERIDIAN HEALTHCARE
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
- Arise Medical Llc
Sources (1)
- FDA UDI c0e3cbee-73bd-4a53-8116-2f3ff1cd70e6 34 fields · synced May 31, 2026