FDA.reportPublic FDA data

BD Vacutainer® Safety-Lok™ Blood Collection Set

Primary DI
30382903672944
Brand
BD Vacutainer® Safety-Lok™ Blood Collection Set
Company
BECTON, DICKINSON AND COMPANY
Model
367294
Catalog number
367294
Device description
WINGSET SLBCS 25X.75 7LUER
Published
2016-07-28
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
K980414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980414000VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SETBd Becton Dickinson Vacutainer Systems Preanalytic1998-03-03JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903672948PackageGS14In Commercial Distribution
30382903672944PrimaryGS10
00382903672943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290367294850382903672948
3038290367294430382903672944
00382903672943003829036729433829036729430382903672943

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Millimeter
Needle Gauge25Gauge

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, Specify00Room Temperature
Special Storage Condition, Specify00This way up

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
50
Lot or batch
true
Expiration date on label
true

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