ExactaMix Pharmacy Compounding Device

ExactaMix Pharmacy Compounding Device
EXACTAMIX - EXACTA-M

Device Description

A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

80.00
10.00

Handling Environment Temperature - Degrees Celsius

30.00
15.00

Storage Environment Humidity - Percent (%) Relative Humidity

80.00
10.00

Storage Environment Temperature - Degrees Celsius

64.00
0.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NEP

Device Name: System/Device, Pharmacy Compounding

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5440

Third Party Flag: N

Medical Specialty: HO

Device Identifiers

Device Id: 00085412586557

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A