Atellica CI Rack Handler

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Atellica CI Rack Handler FDA UDI
Generic Name: Specimen processing instrument IVD FDA UDI
Device Name: Atellica CI Rack Handler FDA UDI
Model / Reference: 10947348 FDA UDI
Description: Atellica CI Rack Handler FDA UDI

Identifiers

Catalog Number: 10947348 FDA UDI
Primary DI / UDI-DI: 00630414229560 FDA UDI
510(k) Number: K222116 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Specimen processing instrument IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Specimen processing instrument IVD

Atellica CI Rack Handler by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K222116 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 2a5d082d-cced-4b37-8f2d-957283b83f90 36 fields · synced Jun 7, 2026