T34L Syringe Pump

GUDID B101100100SLA0

CME AMERICA LLC

Syringe pump Syringe pump Bedside syringe pump

• Primary Device ID: B101100100SLA0
• NIH Device Record Key: f3b322ad-b90d-428b-812b-ce60f47d269a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T34L Syringe Pump
• Version Model Number: 100-100SLA
• 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: 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B101100100SLA0 [Primary]

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: 2018-12-03
• Device Publish Date: 2016-09-15

Devices Manufactured by CME AMERICA LLC

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• 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
• B101100100SLA0 - T34L Syringe Pump: 2018-12-03