CADD

GUDID 15019517150292

Smiths Medical ASD, Inc.

General-purpose infusion pump, line-powered Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 15019517150292
• NIH Device Record Key: 2728f730-d9ed-4dd7-a913-de84d9fa072d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADD
• Version Model Number: 21-2127-0105-01
• Company DUNS: 082005361
• Company Name: Smiths Medical ASD, Inc.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517150292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111275

FDA Product Code

• FRN: Pump, infusion

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: 2020-02-18
• Device Publish Date: 2020-02-10

On-Brand Devices [CADD]

• 15019517139075: 21-2174-25
• 15019517139068: 21-2172-25
• 15019517126617: 2120
• 15019517126600: 2120
• 15019517126594: 2120
• 15019517126587: 2120
• 30610586042717: 21-2170-64
• 30610586034507: 21-7115-24
• 50695085804008: 80-01-040
• 15019517173864: 21-2131-01
• 15019517155020: 21-2112-0402-249
• 15019517155013: 21-2112-0402-78
• 15019517154993: 21-2112-0402-51
• 15019517154894: 21-2111-0402-249
• 15019517154887: 21-2111-0402-78
• 15019517154290: 21-2111-0402-51
• 10610586043543: 21-2137-0100-51
• 10610586043246: 22-1060-51
• 10610586041037: 21-2111-0400-51
• 10610586039102: 21-6120-24
• 10610586035012: 21-2183-25
• 10610586035005: 21-2135-25
• 10610586034992: 21-2140-25
• 10610586031861: 21-2184-51
• 10610586031212: 21-2160-51
• 10610586028113: 21-6081-04
• 10610586028090: 21-6088-04
• 10610586026669: 21-3819-20
• 35019517184239: 21-7349-24
• 35019517184222: 21-7147-24
• 35019517184208: 21-7044-24
• 15019517171969: 21-2131-25
• 15019517165753: 21-2137-0101-25
• 15019517150568: 21-2120-0105-231
• 15019517150292: 21-2127-0105-01
• 15019517150148: 21-2125-0105-01
• 15019517150001: 21-2120-0105-01
• 15019517149999: 21-2120-0105-00
• 15019517155006: 21-2112-0402-51L
• 15019517154986: 21-2111-0402-51L
• 35019517191824: 21-7343-24
• 35019517191770: 21-7364-24
• 35019517191732: 21-7361-24
• 35019517191718: 21-7345-24
• 35019517191701: 21-7365-24
• 35019517184253: 21-7665-24
• 35019517184246: 21-7649-24
• 35019517161971: 21-7386-24
• 35019517161964: 21-7363-24
• 35019517161957: 21-7346-24