Ambu® SPUR® II Pediatric Resuscitator 530612054

GUDID 05707480150106

w/Inspiratory Filter & Manometer

Ambu A/S

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 05707480150106
• NIH Device Record Key: 8a604bd0-b2cb-4ad5-94ca-8f60d984b7f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu® SPUR® II Pediatric Resuscitator
• Version Model Number: 530612054
• Catalog Number: 530612054
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480150090 [Primary]
GS1	05707480150106 [Package]; Contains: 05707480150090; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• OEV: Cardiopulmonary resuscitation aid kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-28
• Device Publish Date: 2024-02-20

On-Brand Devices [Ambu® SPUR® II Pediatric Resuscitator]

• 05707480152827: Single Patient Use Resuscitator
• 05707480152742: Single Patient Use Resuscitator
• 05707480152728: Single Patient Use Resuscitator
• 05707480152360: Single Patient Use Resuscitator
• 05707480152346: Single Patient Use Resuscitator
• 05707480152803: Single Patient Use Resuscitator
• 05707480152667: Single Patient Use Resuscitator
• 05707480152643: Single Patient Use Resuscitator
• 05707480152506: Single Patient Use Resuscitator
• 05707480152483: Single Patient Use Resuscitator
• 05707480152469: Single Patient Use Resuscitator
• 05707480152384: Single Patient Use Resuscitator
• 05707480153541: Single Patient Use Resuscitator
• 05707480152780: Single Patient Use Resuscitator
• 05707480152681: Single Patient Use Resuscitator
• 05707480152629: Single Patient Use Resuscitator
• 05707480152445: Single Patient Use Resuscitator
• 05707480150762: Single Patient Use Resuscitator
• 05707480150700: Single Patient Use Resuscitator
• 05707480150625: Single Patient Use Resuscitator
• 05707480150601: Single Patient Use Resuscitator
• 05707480150427: w/ Manometer
• 05707480163472: w/ Expiratory Filter, Manometer & PEEP valve
• 05707480163458: w/ Expiratory Filter, Manometer & PEEP valve
• 05707480150724: Single Patient Use Resuscitator
• 05707480150687: with Filter
• 05707480150588: w/ Manometer
• 05707480150526: Single Patient Use Resuscitator
• 05707480150328: Single Patient Use Resuscitator
• 05707480150205: Single Patient Use Resuscitator
• 05707480150120: Single Patient Use Resuscitator
• 05707480150083: Single Patient Use Resuscitator
• 05707480150021: Single Patient Use Resuscitator
• 05707480149964: w/Expiratory Filter
• 05707480150069: Single Patient Use Resuscitator
• 05707480152704: Single Patient Use Resuscitator
• 05707480153565: Single Patient Use Resuscitator
• 05707480153527: Single Patient Use Resuscitator
• 05707480152902: Single Patient Use Resuscitator
• 05707480152605: Single Patient Use Resuscitator
• 05707480152582: Single Patient Use Resuscitator
• 05707480152520: Single Patient Use Resuscitator
• 05707480152421: Single Patient Use Resuscitator
• 05707480152407: Single Patient Use Resuscitator
• 05707480152322: Single Patient Use Resuscitator
• 05707480151523: Single Patient Use Resuscitator
• 05707480150106: w/Inspiratory Filter & Manometer
• 05707480150045: Single Patient Use Resuscitator
• 05707480150007: Single Patient Use Resuscitator
• 05707480149988: w/PEEP Valve 20