FDA.reportPublic FDA data

Saline Solution (0.85%)

Primary DI
B08816120
Brand
Saline Solution (0.85%)
Company
BIO-MED DIAGNOSTICS, INC.
Model
1612
Catalog number
11-612-001
Device description
Saline Solution (0.85%) is a saline solution for viral specimens.
Published
2020-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B08816121PackageHIBCC1In Commercial Distribution
B08816122PackageHIBCC50In Commercial Distribution
B08816120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterile saline suspension medium/diluent IVDA sterile saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
605213545
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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