ACTion Block Pump, 1000ml, 1-6 ml/hrMultiBolus II 4191501000

GUDID 05707480111510

ACTion Block 400 ml, w Multi Bolus II, 1-6 ml/hr

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480111510
• NIH Device Record Key: bbb247b6-a2a6-4b3b-8f87-70c97a772c5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTion Block Pump, 1000ml, 1-6 ml/hrMultiBolus II
• Version Model Number: 4191501000
• Catalog Number: 4191501000
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Dimensions

• Total Volume: 1000 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480111503 [Primary]
GS1	05707480111510 [Package]; Contains: 05707480111503; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072053

FDA Product Code

• MEB: PUMP, INFUSION, ELASTOMERIC

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: 2018-08-13
• Device Publish Date: 2018-07-13

Devices Manufactured by Ambu A/S

• 05707480161867 - Ambu® aScope™ Gastro Large: 2024-04-25 Gastroscope
• 05707480021697 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size neonate
• 05707480021703 - Disposable Face Masks: 2024-04-16 Face mask
• 05707480021710 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size toddler, with hook ring,
• 05707480005635 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size small adult/child, with hook ring
• 05707480021734 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size medium adult, with hook ring
• 05707480021741 - Disposable Face Masks: 2024-04-16 Ambu disposable face mask, size large adult, with hook ring
• 05707480150441 - Ambu® SPUR® II Pediatric Resuscitator: 2024-03-07 w/CO2 Detector