AUTOSPIN MAR01 Sterile disposable convenience kit MAR01-BTI-80-O

GUDID M896MAR01BTI80O0

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration
Primary Device IDM896MAR01BTI80O0
NIH Device Record Key182b3ae9-7728-4748-8719-a1eb86122c4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOSPIN MAR01 Sterile disposable convenience kit
Version Model NumberMAR01-BTI-80-O
Catalog NumberMAR01-BTI-80-O
Company DUNS809012870
Company NameARTERIOCYTE MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone866-660-2674
Emailcustomerservice@arteriocyte.co
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
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
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
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
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
HIBCCM896MAR01BTI80O0 [Primary]
HIBCCM896MAR01BTI80O1 [Package]
Package: Box [1 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-09
Device Publish Date2016-09-09

On-Brand Devices [AUTOSPIN MAR01 Sterile disposable convenience kit]

M896MAR01BTI80O0Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
M896MAR01BTI800Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
M896MAR01BTI45O0Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
M896MAR01BTI450Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.