FDA.reportPublic FDA data

BD Vacutainer® Buffered Cit. Na. (9:1) 0.105M = 3.2% 4.5mL

Primary DI
50382903680264
Brand
BD Vacutainer® Buffered Cit. Na. (9:1) 0.105M = 3.2% 4.5mL
Company
BECTON, DICKINSON AND COMPANY
Model
368026
Catalog number
368026
Device description
BD Vacutainer® Buffered Sodium Citrate: 0.5 mL – 0.105M
Published
2016-10-25
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
K945952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945952000VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEBd Becton Dickinson Vacutainer Systems Preanalytic1995-01-18JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903680264PrimaryGS10
00382903680269Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290368026450382903680264
00382903680269003829036802693829036802690382903680269

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, sodium citrateA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., for plasma coagulation studies, mononuclear cell preparation). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
1000
DM exempt
true
Lot or batch
true
Expiration date on label
true

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