Identity
- Trade Name
- Mini-Heart®, Lo-Flo Continuous Nebulizer FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- Mini-Heart®, Lo-Flo Continuous Nebulizer, Neonatal Valved Tee,7' FDA UDI
- Model / Reference
- 100611C FDA UDI
- Description
- Mini-Heart®, Lo-Flo Continuous Nebulizer, Neonatal Valved Tee,7' FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078000201 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, single-use
Mini-Heart®, Lo-Flo Continuous Nebulizer by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Westmed, Inc.
Sources (1)
- FDA UDI dc3474c6-c76d-4b64-9128-e68a4bfae0b0 33 fields · synced Jun 1, 2026