Identity
- Trade Name
- BodyMed FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- BodyMed Reusable Nebulizer Kit including reusable nebulizer bottle,T connector, mouth piece, 2M oxygen tube, corrugated tube FDA UDI
- Model / Reference
- BDMRNK FDA UDI
- Description
- BodyMed Reusable Nebulizer Kit including reusable nebulizer bottle,T connector, mouth piece, 2M oxygen tube, corrugated tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815991025068 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
BodyMed by Boxout, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Boxout, Llc
Sources (1)
- FDA UDI b5926111-a17c-4e34-9558-a2ff21fb9802 34 fields · synced Jun 8, 2026