CADD

CADD - 21-2112-0402-249

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FPA

Device Name: Set, Administration, Intravascular

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: Y

Medical Specialty: HO

Code: MEA

Device Name: Pump, Infusion, Pca

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 880.5725

Third Party Flag: N

Medical Specialty: HO

Code: PYR

Device Name: Neuraxial Administration Set - Intrathecal Delivery

Device Class: 2

Physical State: Administration sets are made of polymers and connected to infusion pumps or medication containers such as syringes or flexible medication containers.

Definition: Neuraxial Administration Sets used to deliver fluids to the intrathecal space.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Administration sets are made of polymers, are connected to infusion pumps or medication containers (i.e. syringes, flexible medication containers), and are used to deliver fluids from the storage container or pump into the intrathecal space. These sets may include ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial connectors.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: intrathecal space

Regulation Number: 880.5440

Third Party Flag: N

Medical Specialty: HO

Code: MRZ

Device Name: Accessories, Pump, Infusion

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 880.5725

Third Party Flag: N

Medical Specialty: HO

Device Id: 15019517155020

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