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Ambu® SPUR® II Pediatric Resuscitator
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 330006000Model SPUR Mask
by Ambu A/S
Identity
- Trade Name
- Ambu® SPUR® II EUDAMEDAmbu® SPUR® II Pediatric Resuscitator FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- SPUR Mask EUDAMEDwith Filter FDA UDI
- Model / Reference
- SPUR Mask EUDAMED330006000 EUDAMED531613017 FDA UDI
- Description
- with Filter FDA UDI
Identifiers
- Catalog Number
- 531613017 FDA UDI
- Primary DI / UDI-DI
- 05707480032624 EUDAMED05707480150670 FDA UDI
- Basic UDI-DI
- 570748030101001005W EUDAMED
- FDA Product Code
- OEV FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Medical Purpose
- Intended for pulmonary resuscitation EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Ambu® SPUR® II Pediatric Resuscitator by Ambu A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (2)
- FDA UDI b24e6dc6-a1b4-4b9e-85fb-e753b768bdb7 36 fields · synced Jul 8, 2026
- EUDAMED da0b73d3-9573-40c4-94fe-7d4420b80abf 61 fields · synced Jul 8, 2026