Ambu® SPUR® II Pediatric Resuscitator

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Ambu® SPUR® II Pediatric Resuscitator FDA UDI
Generic Name: Pulmonary resuscitator, manual, single-use FDA UDI
Device Name: Single Patient Use Resuscitator FDA UDI
Model / Reference: 530614000 FDA UDI
Description: Single Patient Use Resuscitator FDA UDI

Identifiers

Catalog Number: 530614000 FDA UDI
Primary DI / UDI-DI: 05707480152674 FDA UDI
FDA Product Code: OEV 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Pulmonary resuscitator, manual, single-use

Ambu® SPUR® II Pediatric Resuscitator 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 39223c80-c01a-4966-9594-3913757e556d 37 fields · synced May 30, 2026