FDA.reportPublic FDA data

Magellan Complete Disposable Kit

Primary DI
M896AMS3000
Brand
Magellan Complete Disposable Kit
Company
Arteriocyte Medical Systems, Inc.
Model
AMS300
Catalog number
AMS300
Device description
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M896AMS3001PackageHIBCC5In Commercial Distribution
M896AMS3000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15.5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
888-705-4786customerservice@istobiologics.com

Regulatory Flags#

DUNS number
809012870
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M896AMS1000Magellan Autologous Platelet Separator SystemAMS100AMS1002016-09-09
M896AMS3050Magellan Basic disposable kitAMS305AMS3052016-09-12
M896AMS3100Magellan Complete One Source KitAMS310AMS3102016-09-12
M896BTI2000Magellan Autologous Platelet Separator SystemBTI200BTI2002016-09-09
M896CLPTPK1010CP Disposable KitCLPT-PK-101CLPT-PK-1012018-12-12
M896CLPTPK101450Cellpoint CP Disposable Kit with 45mm Lightning NeedleCLPT-PK-101-45CLPT-PK-101-452020-02-26
M896IBIA55600Small Anchor Awl 5mmIB-IA-5560IB-IA-55602022-12-19
M896IBIA65700Medium Anchor Awl 6mmIB-IA-6570IB-IA-65702022-12-19
M896IBIA75800Large Anchor Awl 7mmIB-IA-7580IB-IA-75802022-12-19
M896IBIA85900Xlarge Anchor Awl 8mmIB-IA-8590IB-IA-85902022-12-19
M896IBK00010Fibrant Instrument Kit IB-K-0001IB-K-00012022-12-19
M896IQSPMX1500InQu Matrix 5x10cmIQSP-MX-150IQSP-MX-1502022-06-23
M896IQSPPP1010InQu Paste Mix Plus 1.25ccIQSP-PP-101IQSP-PP-1012018-08-01
M896IQSPPP1020InQu Paste Mix Plus 2.5ccIQSP-PP-102IQSP-PP-1022018-08-01
M896IQSPPP1050InQu Paste Mix Plus 5ccIQSP-PP-105IQSP-PP-1052018-08-01
M896IQSPPP1100InQu Paste Mix Plus 10ccIQSP-PP-110IQSP-PP-1102018-08-01
M896MAG1000Magellan Autologous Platelet Separator SystemMAG100MAG1002016-09-09
M896MAG2000Magellan Autologous Platelet Separator SystemMAG200MAG2002016-09-09
M896MAR0MAX450Magellan MAR0Max QuickDraw Convenience KitMAR0Max45MAR0Max452016-09-09
M896PRCDIA1200Precise Diamond - 120 mL LP Kit PRC-DIA-120PRC-DIA-1202023-05-30

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