FDA.reportPublic FDA data

Filter Sampler Blood Serum Filters

Primary DI
20817139020175
Brand
Filter Sampler Blood Serum Filters
Company
POREX CORPORATION
Model
IB Model
Catalog number
40537
Device description
13mm x 1 5/8" Filter Sampler Blood Serum Filters IB Model
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GIMTubes, Vacuum Sample, With Anticoagulant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817139020175PackageGS140In Commercial Distribution
10817139020178PrimaryGS10
00817139020171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081713902017520817139020175
1081713902017810817139020178
00817139020171008171390201718171390201710817139020171

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, no additive/metal-freeA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum with no additive and free of any metals. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations including trace elements, serology, and toxicology). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186972733
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817139020017Filter Sampler Blood Serum FiltersStandard Model62122016-09-14
10817139020024Filter Sampler Blood Serum FiltersStandard Model62042016-09-14
10817139020031Filter Sampler Blood Serum FiltersStandard Model62282016-09-14
10817139020048Filter Sampler Blood Serum FiltersStandard Model62372016-09-14
10817139020055Filter Sampler Blood Serum FiltersStandard Model62422016-09-14
10817139020062Filter Sampler Blood Serum FiltersStandard Model62142016-09-14
10817139020079Filter Sampler Blood Serum FiltersStandard Model62212016-09-14
10817139020086Filter Sampler Blood Serum FiltersStandard Model62222016-09-14
10817139020093Filter Sampler Blood Serum FiltersStandard Model64142016-09-14
10817139020116Filter Sampler Blood Serum FilterIB Model62512016-09-08
10817139020123Filter Sampler Blood Serum FiltersIB Model62592016-09-14
10817139020130Filter Sampler Blood Serum FiltersIB Model62412016-09-14
10817139020147Filter Sampler Blood Serum FiltersIB Model62582016-09-14
10817139020161Filter Sampler Blood Serum FiltersIB Model404752016-09-14
10817139020178Filter Sampler Blood Serum FiltersIB Model405372016-09-14
10817139020185Filter Sampler Dispense FilterStandard Model64362016-09-14
10817139020192Filter Sampler Dispense FilterStandard Model64372016-09-14
10817139020208Filter Sampler Dispense+ FilterStandard Model64392016-09-14
10817139020338Fisherbrand Serum FilterStandard Model02-681-542016-09-14
10817139020345Fisherband Serum FilterStandard Model02-681-512016-09-14

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Primary DI, Brand, Company table
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50192253051214CovidienCardinal Health 200, LLCGIM2025-01-14
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20192253051183MonojectCardinal Health 200, LLCGIM2024-10-08
50192253051184MonojectCardinal Health 200, LLCGIM2024-10-08
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50382903666169BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666176BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
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20192253050926MonojectCardinal Health 200, LLCGIM2024-02-28
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20192253051077MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051084MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051107MonojectCardinal Health 200, LLCGIM2024-02-28