BMP Accessory Set

BMP Accessory Set
Spectra Optia® - 11300

A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PKG

Device Name: Bone Marrow Processing Device To Support Hematopoietic Reconstitution

Device Class: 2

Physical State: May include centrifuge, pumps, valves, computerized safety/control systems, sterile single-use disposable tubing, and bags

Definition: Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Relies on a centrifugal field and may include filtration methods for separation of harvested bone marrow into its cellular and non-cellular components.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Bone marrow aspirates obtained from the iliac crest of human donors, processed and infused into the recipient¿s circulatory system

Regulation Number: 864.9245

Third Party Flag: N

Medical Specialty: HE

Device Id: 05020583113008

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

Device Id: 35020583113009

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05020583113008

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A