Autologous Platelet Separator AMS100

GUDID M896AMS1001

MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system centrifuge
Primary Device IDM896AMS1001
NIH Device Record Key6ac7e9a2-a877-4f18-af56-02e932c5a969
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutologous Platelet Separator
Version Model NumberAMS100
Catalog NumberAMS100
Company DUNS809012870
Company NameARTERIOCYTE MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-660-2674
Emailcustomerservice@arteriocyte.com
Phone866-660-2674
Emailcustomerservice@arteriocyte.com
Phone866-660-2674
Emailcustomerservice@arteriocyte.com
Phone866-660-2674
Emailcustomerservice@arteriocyte.com
Phone866-660-2674
Emailcustomerservice@arteriocyte.com
Phone866-660-2674
Emailcustomerservice@arteriocyte.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM896AMS1000 [Primary]
HIBCCM896AMS1001 [Package]
Contains: M896AMS1000
Package: Box [1 Units]
In Commercial Distribution

FDA Product Code

JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2016-09-09

On-Brand Devices [Autologous Platelet Separator]

M896TRU2001MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an
M896TRU1001MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an
M896MAG2001MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an
M896MAG1001MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an
M896BTI2001MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an
M896AMS1001MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an

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