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Basic platelet separator kit

FDA UDIEUDAMED

by Arteriocyte Medical Systems, Inc.

Identity

Trade Name
Basic platelet separator kit FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Device Name
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument FDA UDI
Model / Reference
BTI305 FDA UDI
Description
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument FDA UDI

Identifiers

Catalog Number
BTI305 FDA UDI
Primary DI / UDI-DI
M896BTI3050 FDA UDI
GMDN Term
Haematological concentrate system preparation kit, platelet concentration FDA UDI

Classification

Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Basic platelet separator kit by Arteriocyte Medical Systems, Inc. — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arteriocyte Medical Systems, Inc.

Sources (2)

  • FDA UDI c9350ab4-4cf6-4782-91f2-24cc5ec37451 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026