Amplifine SM-PRP-30-BD
GUDID 00350224000134
Amplifine HD PRP Tube 30ml, Blood Draw kit
SUNEVA MEDICAL, INC.
Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous blood collection tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube Autologous platelet-based product centrifuge tube| Primary Device ID | 00350224000134 |
| NIH Device Record Key | 7caa072a-ec12-468c-8dfe-52c15a6c9d3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplifine |
| Version Model Number | 30ml - BD |
| Catalog Number | SM-PRP-30-BD |
| Company DUNS | 012844615 |
| Company Name | SUNEVA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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
Device Dimensions
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
| Total Volume | 30 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00350224000134 [Primary] |
FDA Product Code
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-08 |
| Device Publish Date | 2020-12-31 |
On-Brand Devices [Amplifine]
| 00350224000134 | Amplifine HD PRP Tube 30ml, Blood Draw kit |
| 00350224000127 | Amplifine HD PRP Tube 15ml, Blood Draw Kit |
| 10350224000117 | Amplifine HD PRP Tube 30ml |
| 10350224000100 | Amplifine HD PRP tube 15ml |
| 00350224000165 | Amplifine HD PRP convenience kit. Large Holder 30ml Vacutainer, 10 pack. |
| 00350224000158 | Amplifine HD PRP convenience kit. BD Vacutainer & Tourniquet, 10 pack |
Trademark Results [Amplifine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPLIFINE 88846367 not registered Live/Pending |
Suneva Medical, Inc. 2020-03-24 |
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