CADD 21-2120-0103-51

GUDID 15019517096378

SMITHS MEDICAL MD, INC.

General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered Bedside infusion pump 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: 15019517096378
• NIH Device Record Key: 8390a567-a784-4bb1-886f-6fe4ada238d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADD
• Version Model Number: 2120
• Catalog Number: 21-2120-0103-51
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517096378 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-17
• Device Publish Date: 2017-03-23

On-Brand Devices [CADD]

• 00610586031901: 21-2195-51
• 00610586026693: 21-6244-20
• 00610586019145: 21-6143-01
• 00610586018636: 21-5814-01
• 00610586017073: 21-3815-01
• 00610586017004: 21-3802-01
• 00610586016977: 21-3801-01
• 00610586016960: 21-3800-01
• 30610586034583: 21-2171-25
• 30610586029695: 21-2407-01
• 15019517126884: 21-0270-25
• 15019517101041: 2110
• 15019517101034: 2110
• 15019517101027: 2110
• 15019517101010: 2110
• 15019517101003: 2110
• 15019517099690: 2110
• 15019517096392: 2120
• 15019517096385: 2120
• 15019517096378: 2120
• 15019517084368: 21-2120-0103-01
• 15019517084344: 21-2120-0103-00
• 10610586039232: 21-2112-0100-51
• 10610586038808: 21-2112-0300-01
• 10610586038778: 21-2111-0300-01
• 10610586035098: 21-6220-64
• 10610586034602: 21-2169-24
• 10610586034565: 21-2168-25
• 10610586034558: 21-2167-25
• 10610586023040: 21-6117-24
• 10610586019326: 21-6218-24
• 10610586019180: 21-6165-24
• 10610586025181: 21-4653-24
• 10610586043161: 21-2165-64
• 10610586035036: 21-2189-25
• 10610586031878: 21-2188-25
• 10610586034596: 21-2166-24
• 10610586026966: 21-6286-04
• 10610586026959: 21-6285-04
• 10610586026942: 21-6284-04
• 10610586026928: 21-6281-04
• 10610586021725: 21-6240-01
• 10610586019227: 21-6202-01
• 10610586045387: 21-2193-0401-25
• 10610586044168: 21-2194-0401-25
• 10610586042980: 21-2191-0300-25
• 10610586042737: 21-2194-0301-01
• 10610586042720: 21-2193-0301-01
• 10610586041327: 21-2136-0200-25
• 10610586033803: 21-2194-249