FDA.report

CARDINAL HEALTH

Primary DI
10885380163692
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH3158-8
Catalog number
CH3158-8
Device description
Blood Bank Saline Buffered 10L
Published
2019-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GIFDILUENT, BLOOD CELL

Product Code Classifications

CodeDeviceSpecialtyClass
GIFDiluent, Blood CellHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380163692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538016369210885380163692

GMDN Terms

TermDefinition
Red cell antibody diluent IVD, reagentA substance or reactant that is an antibody-free solution intended to be used as a diluent in the immunohaematological testing of a clinical specimen for the semi-quantitative determination of a red blood cell antibody, using a serial dilution or titration technique.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
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
true
Sterilization required before use
false

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