Ambu® SPUR® II Adult Resuscitator

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Ambu® SPUR® II Adult Resuscitator FDA UDI
Generic Name: Cardiopulmonary resuscitation kit, single-use FDA UDI
Device Name: Single Patient Use Resuscitator FDA UDI
Model / Reference: 520211000E FDA UDI
Description: Single Patient Use Resuscitator FDA UDI

Identifiers

Catalog Number: 520211000E FDA UDI
Primary DI / UDI-DI: 05707480153596 FDA UDI
FDA Product Code: OEV FDA UDI
GMDN Term: Cardiopulmonary resuscitation kit, 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cardiopulmonary resuscitation kit, single-use

A single-use, manual resuscitation device designed for adult patients in emergency situations. This comprehensive guide provides an overview of its key features, regulatory compliance, and FAQs.

Similar devices

Also classified as Cardiopulmonary resuscitation kit, single-use.

Ever Ready First Aid — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Aquatic Solutions — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
BROSELOW™ — Airlife, Inc. · Class II
WNLProducts — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
BROSELOW™ — Airlife, Inc. · Class II
compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
BROSELOW™ — Airlife, Inc. · Class II

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 fc27387a-3204-4ce7-92d2-2522570ddd69 36 fields · synced Aug 1, 2026