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SPUR® II Pediatric Resuscitatorwith Filter
FDA UDIClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- SPUR® II Pediatric Resuscitatorwith Filter FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- SPUR II Ped, Tube Resv, Tod FM, Mercury Filter, Manometer FDA UDI
- Model / Reference
- 531613017 FDA UDI
- Description
- SPUR II Ped, Tube Resv, Tod FM, Mercury Filter, Manometer FDA UDI
Identifiers
- Catalog Number
- 531613017 FDA UDI
- Primary DI / UDI-DI
- 05707480109814 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
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary resuscitator, manual, single-use
SPUR® II Pediatric Resuscitatorwith Filter 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 d8d8d2d0-7a77-4057-899c-b8e847baa592 38 fields · synced May 31, 2026