BOWL BT125E 125ML AUTOTRANSFUSION 9PK

BOWL BT125E 125ML AUTOTRANSFUSION 9PK
NA - BT125E

Device Description

A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Store in a dry place away from extremes of temperature.

Storage Environment Temperature - Degrees Celsius

50.00
N/A

Device Sizes

125 ML Volume

125 ML Volume

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: CAC

Device Name: Apparatus, Autotransfusion

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5830

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 10673978522224

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00673978522227

Package Quantity: 9

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PK

Device Id: 00673978522227

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