Identity
- Trade Name
- Well Baby Bassinet FDA UDI
- Generic Name
- Neonatal bed FDA UDI
- Device Name
- ASSY-LAU, BASSINET WITH SIDE PANEL, WITH SPACER AND LABELS, NAT MPL-MAKE FDA UDI
- Model / Reference
- BN4 FDA UDI
- Description
- ASSY-LAU, BASSINET WITH SIDE PANEL, WITH SPACER AND LABELS, NAT MPL-MAKE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682119320 FDA UDI
- FDA Product Code
- NZG FDA UDI
- GMDN Term
- Neonatal bed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5145 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Well Baby Bassinet by Datex-Ohmeda Inc. — 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
- Datex-Ohmeda Inc.
Sources (1)
- FDA UDI e516a16d-1e4e-4903-a4d4-c23e631e72ea 35 fields · synced Jun 7, 2026