Identity
- Trade Name
- LEADER FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- LDR Pediatric Nebulizer System Betty the Pig FDA UDI
- Model / Reference
- 5238506 FDA UDI
- Description
- LDR Pediatric Nebulizer System Betty the Pig FDA UDI
Identifiers
- Catalog Number
- 5238506 FDA UDI
- Primary DI / UDI-DI
- 00096295128789 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Leader by Cardinal Health 110, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 110, Inc.
Sources (1)
- FDA UDI 627dacb3-92aa-430b-9fc2-12a43783e90d 38 fields · synced May 30, 2026