BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

SPUR® II Infant Resuscitator

DI: 05707480162918 · Model: 540236047 · Ambu A/S

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: SPUR® II Infant Resuscitator
Primary DI: 05707480162918
Version / Model: 540236047
Catalog Number: 540236047
Company Name: Ambu A/S
Labeler DUNS: 305682023
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-06-06
Public Version: 1
Public Version Date: 2025-06-16
Public Version Status: New
Public Device Record Key: 36efae04-dccc-4ef0-9e76-75a930fd3e66

Device Description

SPUR II Inf Bag Res, Neon & Inf FM, Mano, Disp PEEP, 10' Ox

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Conditional
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEV	Cardiopulmonary resuscitation aid kit	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35693	Cardiopulmonary resuscitation kit, single-use	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480162925	GS1	Case	12	In Commercial Distribution
Primary	05707480162918	GS1

Customer Contacts

Phone: +1(410)768-6464
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 15 – 25 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: -18 – 50 Degrees Celsius