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SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator
FDA UDIClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Ambu SPUR II Infant with open reservoir, with Duraclear face mask size neonate, with 22/15 inspiratory filter 12 pcs/box FDA UDI
- Model / Reference
- 544211033 FDA UDI
- Description
- Ambu SPUR II Infant with open reservoir, with Duraclear face mask size neonate, with 22/15 inspiratory filter 12 pcs/box FDA UDI
Identifiers
- Catalog Number
- 544211033 FDA UDI
- Primary DI / UDI-DI
- 05707480034079 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use 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
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
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
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 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 08a85d1f-4ff2-4e3a-b833-773bf08a2c4f 38 fields · synced Jun 8, 2026