Catheter Set, 190mm Cut-to Size, 9" Introducer

GUDID 05707480121816

Catheter set (190mm cut-to size + 9" introducer+Dressings), stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480121816
• NIH Device Record Key: c5f1e365-c581-4a62-9a73-a6541092aa58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catheter Set, 190mm Cut-to Size, 9" Introducer
• Version Model Number: 418000530
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 190 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480121762 [Primary]
GS1	05707480121809 [Package]; Contains: 05707480121762; Package: [10 Units]; In Commercial Distribution
GS1	05707480121816 [Package]; Contains: 05707480121809; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061409

FDA Product Code

• MEB: Pump, Infusion, Elastomeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-19

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