HARVEST®
GUDID 05020583514805
SmartPrep® 3 Multi-Cellular Processing System
TERUMO BCT, INC.
Haematological concentrate system centrifuge| Primary Device ID | 05020583514805 |
| NIH Device Record Key | 566d9d81-3417-42bd-9d92-5ccdbef5fd9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HARVEST® |
| Version Model Number | 51480 |
| Company DUNS | 801679200 |
| Company Name | TERUMO BCT, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583514805 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK130068
FDA Product Code
| JQC | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-16 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [HARVEST® ]
| 05020583514997 | SmartPrep® 3 Multi-Cellular Processing System, Red Cell Reduction Hardware Kit |
| 05020583514935 | SmartPrep® 3 Multi-Cellular Processing System, Balance Weight/ tube Adapter TA-60 |
| 05020583514928 | TA-30 Balance Weight / Tube Adapter PRP30 BMAC® |
| 05020583514898 | SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-30 |
| 05020583514836 | SmartPrep® 2 Centrifuge System |
| 05020583514805 | SmartPrep® 3 Multi-Cellular Processing System |
| 05020583514744 | SmartPRep® 2 Centrifuge System |
| 05020583514720 | SmartPrep® 3 Multi-Cellular Processing System |
| 05020583514034 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-20i PRP Procedure Pack |
| 05020583514010 | Platelet Concentrate (PC) Procedure Pack |
| 05020583514362 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-120n PRP Procedure Pack |
| 05020583514157 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60n PRP Procedure Pack |
| 05020583514140 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-30n PRP Procedure Pack |
| 05020583514102 | LP-10 Clear PRP Kit |
| 05020583514096 | Autologous Platelet Concentrate+ (APC) Procedure Pack, APC-120i PRP Procedure Pack |
| 05020583514089 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-120 Procedure Pack |
| 05020583514072 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60i PRP Procedure Pack |
| 05020583514065 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60 Procedure Pack |
| 05020583514058 | Autologous Platelet Concentrate+ (APC) Procedure Pack, APC-30i PRP Procedure Pack |
| 05020583514041 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-30 Procedure Pack |
| 05020583514027 | Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-20 Procedure Pack |
| 05020583514478 | BBAN-10 Needles(BMAC/BMAC2)11Ga X 110mm |
| 05020583514492 | Graft Delivery Pack |
| 05020583514485 | BAN-25 8Ga BM Aspirate Needle |
| 05020583514003 | Platelet Concentrate (PC) Procedure Pack, PC-30-01 |
Trademark Results [HARVEST]
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