Spectra Optia Bmp Set W/Source Plasmabag
Spectra Optia BMP Set w/Source Plasma Bag - 11300
Device Description
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.
Environmental Conditions
- Keep out of sunlight.
- Protect from rain
- 35.00
- 0.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 05020583113008
Device Type: Unit of Use
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: 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