Identity
- Trade Name
- Oval Silicone Resuscitator, Neonate FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, reusable FDA UDI
- Device Name
- Ambu Oval Silicone Neonate resuscitator with pressure limiting valve (40cm H20) with Ambu single shutter patient valve and Ambu Silicone transparent face mask, blue cuff size 0 and oxygen reservoir tube. Supplied in pouch & carton. FDA UDI
- Model / Reference
- A288004000 FDA UDI
- Description
- Ambu Oval Silicone Neonate resuscitator with pressure limiting valve (40cm H20) with Ambu single shutter patient valve and Ambu Silicone transparent face mask, blue cuff size 0 and oxygen reservoir tube. Supplied in pouch & carton. FDA UDI
Identifiers
- Catalog Number
- A288004000 FDA UDI
- Primary DI / UDI-DI
- 05707480035182 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oval Silicone Resuscitator, Neonate by Ambu A/S — 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
- Ambu A/S
Sources (1)
- FDA UDI a8f0a708-9547-4144-8748-ac66eab92f11 37 fields · synced May 30, 2026