4" introducerStand alone, complementary accessory 418000536

GUDID 05707480111183

4" Peel-away Introducer, double sterile pouch.

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480111183
• NIH Device Record Key: efb41d18-8b6b-4e6e-9d8d-48c8ff146208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4" introducerStand alone, complementary accessory
• Version Model Number: 418000536
• Catalog Number: 418000536
• 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: 4 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480111169 [Primary]
GS1	05707480111176 [Package]; Contains: 05707480111169; Package: [10 Units]; In Commercial Distribution
GS1	05707480111183 [Package]; Contains: 05707480111176; Package: [8 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: 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

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