Identity
- Trade Name
- PMI Probasics® FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Buddy the Dog Pediatric Compressor Nebulizer FDA UDI
- Model / Reference
- 8011 FDA UDI
- Description
- Buddy the Dog Pediatric Compressor Nebulizer FDA UDI
Identifiers
- Catalog Number
- 8011 FDA UDI
- Primary DI / UDI-DI
- 00841447104049 FDA UDI
- 510(k) Number
- K043238 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PMI Probasics® by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K043238 also covers:
- Bentely the Bear Pediatric Nebulizer — ARISE MEDICAL LLC
- 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.
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
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 31dd9d9d-35cd-46cd-a127-c1428c3cdad4 37 fields · synced Jun 8, 2026