Amplifine SM-PRP-30

GUDID 10350224000117

Amplifine HD PRP Tube 30ml

SUNEVA MEDICAL, INC.

Autologous blood collection tube
Primary Device ID10350224000117
NIH Device Record Key6a7fe8bc-d379-4729-a7a5-78a30536e16e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmplifine
Version Model Number30ml
Catalog NumberSM-PRP-30
Company DUNS012844615
Company NameSUNEVA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter
Total Volume30 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100350224000110 [Primary]
GS110350224000117 [Package]
Contains: 00350224000110
Package: Carton [3 Units]
In Commercial Distribution
GS120350224000114 [Package]
Contains: 00350224000110
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-08
Device Publish Date2020-12-31

On-Brand Devices [Amplifine]

00350224000134Amplifine HD PRP Tube 30ml, Blood Draw kit
00350224000127Amplifine HD PRP Tube 15ml, Blood Draw Kit
10350224000117Amplifine HD PRP Tube 30ml
10350224000100Amplifine HD PRP tube 15ml
00350224000165Amplifine HD PRP convenience kit. Large Holder 30ml Vacutainer, 10 pack.
00350224000158Amplifine HD PRP convenience kit. BD Vacutainer & Tourniquet, 10 pack

Trademark Results [Amplifine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMPLIFINE
AMPLIFINE
88846367 not registered Live/Pending
Suneva Medical, Inc.
2020-03-24

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