← Back to catalogue
SPUR® II Pediatric Resuscitatorw/Nellcor CO2 Detector
FDA UDIClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- SPUR® II Pediatric Resuscitatorw/Nellcor CO2 Detector FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- SPUR II Ped, Todd FM, Nellcor Ped Cap, Disp Peep, 6/cs FDA UDI
- Model / Reference
- 530613801N FDA UDI
- Description
- SPUR II Ped, Todd FM, Nellcor Ped Cap, Disp Peep, 6/cs FDA UDI
Identifiers
- Catalog Number
- 530613801N FDA UDI
- Primary DI / UDI-DI
- 05707480109531 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 Pediatric Resuscitatorw/Nellcor CO2 Detector 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA UDI 9317187c-1e5b-406a-92a4-236b20b81962 38 fields · synced Jun 8, 2026