Atellica IM Calibrator 30

Primary DI
00630414294070
Brand
Atellica IM Calibrator 30
Company
Siemens Healthcare Diagnostics Inc.
Model
11206240
Catalog number
11206240
Device description
Calibrator 30 - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100293000ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810Siemens Heatlhcare Diagnostics, Inc.2010-03-19JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293523PrimaryGS10
00630414294070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293523006304142935236304142935230630414293523
00630414294070006304142940706304142940700630414294070

GMDN Terms#

Term, Definition table
TermDefinition
Multiple steroid hormone IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple steroid hormones in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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