500ml Ultimate Lockbox

GUDID B101190900PXCVP0

Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles up to 50 mm in diameter (1), keys (2), Instructions for Use (1).

CME AMERICA LLC

General-purpose infusion pump, line-powered

• Primary Device ID: B101190900PXCVP0
• NIH Device Record Key: bb7ac388-b59b-4ad4-b6ae-c898daeb7251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 500ml Ultimate Lockbox
• Version Model Number: 190-900PXCVP
• Company DUNS: 002125419
• Company Name: CME AMERICA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx
• Phone: 303-936-4945
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B101190900PXCVP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042696

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-11

Devices Manufactured by CME AMERICA LLC

• 00818666020139 - CMExpress® Microbore Set with Needleless Y-Site: 2020-07-16 105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the CMExpress® Infusion Pump
• B101100500PXE0 - Manufacturing Kit CMExpress® Pump: 2020-07-16 Pump, battery 3600mAh, tabletop charger, power cord, Operator's Manual
• 10818666020433 - BodyGuard BodySet: 2019-08-09 26 in. (66 cm) - Blue Stripe
• B101100100POBSC0 - T34 Syringe Pump System: 2018-12-03 Pump, Operator's Manual
• B101100100PSA0 - T34 Syringe Pump System: 2018-12-03 Pump, Operator's Manual
• B101100100PSLA0 - T34L Syringe Pump System: 2018-12-03 Pump, wall charger, operations manual
• B101100100SA0 - T34 Syringe Pump: 2018-12-03
• B101100100SLA0 - T34L Syringe Pump: 2018-12-03