ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC T01-3626-52

GUDID 00630414222950

IVD Complete Blood Count Kit CN-FREE

Siemens Healthcare Diagnostics Inc.

Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count Full blood count IVD, kit, cell count

Primary Device ID	00630414222950
NIH Device Record Key	15c4f866-161b-4511-914c-465532fbb9bc
Commercial Distribution Status	In Commercial Distribution
Brand Name	ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC
Version Model Number	10341169
Catalog Number	T01-3626-52
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from freezing

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414222950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K971998

FDA Product Code

GKL	COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

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