Atellica IM Calibrator E 10995513

GUDID 00630414598406

Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL

Siemens Healthcare Diagnostics Inc.

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Primary Device ID	00630414598406
NIH Device Record Key	444d6bfa-0e66-4904-94a9-36a6d44ab1e6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM Calibrator E
Version Model Number	10995513
Catalog Number	10995513
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	6
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	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 *Store upright
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414190839 [Unit of Use]
GS1	00630414598406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K932955

FDA Product Code

JIS	Calibrator, primary

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	2018-02-06

On-Brand Devices [Atellica IM Calibrator E]

00630414598406	Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
00630414598390	Calibrator E Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
00630414294124	Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL