Antimicrobial DressingStand alone, complementary a 418100501

GUDID 05707480119097

Antimicrobial Dressing 1 x 1

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480119097
• NIH Device Record Key: 6a373628-a9bc-438f-90da-8ffc3fd6201c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Antimicrobial DressingStand alone, complementary a
• Version Model Number: 418100501
• Catalog Number: 418100501
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480119080 [Primary]
GS1	05707480119097 [Package]; Contains: 05707480119080; Package: [10 Units]; In Commercial Distribution
GS1	05707480119103 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-16
• Device Publish Date: 2016-12-27

Devices Manufactured by Ambu A/S

• 05707480164486 - Ambu® aScope™ 5 Cysto HD: 2024-11-14 Flexible Cystoscope, Reverse Deflection
• 05707480164516 - Ambu® aScope™ 5 Cysto HD: 2024-11-14 Flexible Cystoscope, Standard Deflection
• 05707480157136 - Ambu® aScope™ Duodeno 2: 2024-07-29 Duodenoscope
• 05707480006540 - Immobilization Kit, with: 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
• 05707480006557 - Immobilization Kit, with: 2024-07-22 Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
• 05707480037308 - Immobilization Kit, with: 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
• 05707480038626 - Immobilization Kit, with: 2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
• 05707480006601 - Silicone Face Mask: 2024-07-16 Reusable face mask