FDA.reportPublic FDA data

BD Seditainer™ Stand

Primary DI
00382903660162
Brand
BD Seditainer™ Stand
Company
Becton, Dickinson U.K. Limited
Model
366016
Catalog number
366016
Device description
ESR SEDITAINER TUBE STAND FOR 10 TUBES
Published
2024-04-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K953994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953994000SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEMBecton Dickinson Vacutainer Systems1995-09-26JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382903660162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382903660162003829036601623829036601620382903660162

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) rack IVD, scaled measureA dedicated, non-sterile, rack with a build-in graduated scale ruler, with or without a programmable timer or stop-clock, intended to be used to hold erythrocyte sedimentation rate (ESR) tubes containing unmarked columns of blood in an upright and secured position, as required when performing a manual estimation of the ESR of a whole blood clinical specimen. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225931062
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903630470BD Vacutainer® Plus Citrate Tube3630473630472016-07-28
30382903630487BD Vacutainer® Plus Citrate Tube3630483630482016-07-28
30382903679530BD Vacutainer® SST™ II Advance3679533679532016-08-22
30382903679554BD Vacutainer® SST™ II Advance3679553679552016-08-22
30382903679578BD Vacutainer® SST™ II Advance3679573679572016-08-22
30382903688617BD Vacutainer® K2E (EDTA) 7.2mg3688613688612016-07-28
30382903684947BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes3684943684942024-04-04
30382903688846BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes3688843688842024-04-04
30382903688860BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes3688863688862024-04-08
30382903666431BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes3666433666432016-07-28
50382903688864BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes3688863688862024-04-08
30382903685012BD Vacutainer® Z (No Additive) Plus Urine Tube3685013685012024-04-04
50382903684941BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes3684943684942024-04-04
50382903685016BD Vacutainer® Z (No Additive) Plus Urine Tube3685013685012024-04-04
50382903688840BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes3688843688842024-04-04
50382903643788BD A-Line™ Arterial Blood Collection Syringe3643783643782024-04-02
50382903643894BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643893643892024-04-02
50382903643900BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643903643902024-04-02
50382903643917BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643913643912024-04-02
50382903643931BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643933643932024-04-02

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