HARVEST® BMAC®
GUDID 05020583514232
Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120-01 Procedure Pack
TERUMO BCT, INC.
Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration Haematological concentrate system preparation kit, bone marrow concentration| Primary Device ID | 05020583514232 |
| NIH Device Record Key | 476c798c-89da-4dfa-9a29-9d7247b51d8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HARVEST® BMAC® |
| Version Model Number | 51423 |
| Company DUNS | 801679200 |
| Company Name | TERUMO BCT, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583514232 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103340
FDA Product Code
| JQC | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-15 |
Devices Manufactured by TERUMO BCT, INC.
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| 05020583910003 - COBE® 2991 | 2023-06-27 Blood Cell Processor |
| 05020583419506 - IMUGARD | 2022-12-01 elabeling.terumobct.com |
| 35020583700315 - Accessory Platelet Bag with Integrated Sampler | 2022-12-01 elabeling.terumobct.com |
| 05020583112209 - Spectra Optia® | 2022-09-01 Single-Needle Connector |
| 05020583122208 - Spectra Optia® | 2022-09-01 Exchange Sets |
| 05020583700703 - Platelet Additive Solution Connection Adapter | 2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER |
| 05020583705005 - COBE® Spectra | 2022-09-01 Therapeutic Plasma Exchange Set |
Trademark Results [HARVEST]
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