FDA.report

Atellica IM Multi-Diluent 2

Primary DI
00630414599625
Brand
Atellica IM Multi-Diluent 2
Company
Siemens Healthcare Diagnostics Inc.
Model
10995644
Catalog number
10995644
Device description
Multi-Diluent 2 Atellica IM - CONS (2 PK) 1 x 10mL
Published
2020-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
GIFDILUENT, BLOOD CELL

Product Code Classifications

CodeDeviceSpecialtyClass
GIFDiluent, Blood CellHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414599625PrimaryGS10
00630414007687Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599625006304145996256304145996250630414599625
00630414007687006304140076876304140076870630414007687

GMDN Terms

TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store upright
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
064608573
Device count
2
DM exempt
false
Premarket exempt
true
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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