FDA.reportPublic FDA data

BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg

Primary DI
30382903679226
Brand
BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg
Company
BECTON, DICKINSON AND COMPANY
Model
367922
Catalog number
367922
Device description
TUBE GLU PLH 13X75 4.0 PLBL GR
Published
2016-08-22
Public version status
Update
Distribution status
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
K231237000
K901449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231237000BD Vacutainer® Fluoride Blood Collection TubesBecton, Dickinson and Company2024-01-19JKA
K901449000VACUTAINER PLUS WITH HEMOGARD CLOSUREBd Becton Dickinson Vacutainer Systems Preanalytic1990-08-09JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903679220PackageGS110In Commercial Distribution
30382903679226PrimaryGS10
00382903679225Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290367922050382903679220
3038290367922630382903679226
00382903679225003829036792253829036792250382903679225

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/antiglycolyticA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), ammonium oxalate, potassium oxalate, sodium heparin, sodium citrate], and an antiglycolytic agent (e.g., sodium fluoride, lithium iodoacetate). 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 glucose or lactate determinations). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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

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50382903840217BD Introsyte-N, BD Instaflash3840213840212016-10-20
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50382903840316BD Introsyte-N3840313840312016-10-20
50382903840408BD Introsyte3840403840402016-10-20
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00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
00885403523475HemoSphere AltaALTACR1ALTACR12026-08-06
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24

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