FDA.reportPublic FDA data

BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes

Primary DI
50382903688840
Brand
BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes
Company
Becton, Dickinson U.K. Limited
Model
368884
Catalog number
368884
Device description
TUBE LIHEP PLH 13X75 4.0 PLBLCE GN
Published
2024-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K901449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901449000VACUTAINER PLUS WITH HEMOGARD CLOSUREBd Becton Dickinson Vacutainer Systems Preanalytic1990-08-09JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903688840PackageGS110In Commercial Distribution
30382903688846PrimaryGS10
00382903688845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290368884050382903688840
3038290368884630382903688846
00382903688845003829036888453829036888450382903688845

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulantA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. 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 lead, toxicology, nutritional-chemistry, and other plasma chemistry 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
225931062
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
true
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
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
00382903660162BD Seditainer™ Stand3660163660162024-04-18
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
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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