FDA.reportPublic FDA data

BD Vacutainer® SST™

Primary DI
30382903679875
Brand
BD Vacutainer® SST™
Company
BECTON, DICKINSON AND COMPANY
Model
367987
Catalog number
367987
Device description
Tube SST PLC 16X100mm 7.5ml PLBL RD/GR
Published
2016-07-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK050036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK050036000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903679879PackageGS110In Commercial Distribution
30382903679875PrimaryGS10
00382903679874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290367987950382903679879
3038290367987530382903679875
00382903679874003829036798743829036798740382903679874

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, clot activator/separatorA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator, and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length100Millimeter
Total Volume7.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00This way up
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403523437HemoSphere AltaALTAALL1ALTAALL12026-08-06
00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
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00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24

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