Identity
- Trade Name
- Ambu® aBox™ 2 FDA UDI
- Generic Name
- Endoscopic video image display unit FDA UDI
- Device Name
- Ambu aBox 2 US2 FDA UDI
- Model / Reference
- 505001000US2 FDA UDI
- Description
- Ambu aBox 2 US2 FDA UDI
Identifiers
- Catalog Number
- 505001000US2 FDA UDI
- Primary DI / UDI-DI
- 05707480156290 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Endoscopic video image display unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic video image display unit
Ambu® aBox™ 2 by Ambu A/S — 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
- Ambu A/S
Sources (1)
- FDA UDI a018d92f-3cf8-4839-a285-00c0eedde801 36 fields · synced May 31, 2026