Atellica CH CHEM Calibrator 11099411

GUDID 00630414597492

Chemistry Calibrator Atellica CH - CAL 12 x 3.0mL

Siemens Healthcare Diagnostics Inc.

Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator

Primary Device ID	00630414597492
NIH Device Record Key	75d76188-07bb-41a9-a2c7-88e1c57335c6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica CH CHEM Calibrator
Version Model Number	11099411
Catalog Number	11099411
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	12
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	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	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

Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414007106 [Unit of Use]
GS1	00630414597492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161494

FDA Product Code

JIT	Calibrator, secondary

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	2017-12-27

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