FDA.reportPublic FDA data

Medtronic MiniMed Pro-Set Infusion Set, Luer Connection 24in

Primary DI
00382903286126
Brand
Medtronic MiniMed Pro-Set Infusion Set, Luer Connection 24in
Company
Becton, Dickinson and Company Inc
Model
328612
Catalog number
328612
Device description
MINIMED 24IN LUER MMT-290600
Published
2016-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160651000BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company2016-04-07FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903286121PackageGS115In Commercial Distribution
00382903286126PrimaryGS10
00382903672967Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290328612150382903286121
00382903286126003829032861263829032861260382903286126
00382903672967003829036729673829036729670382903672967

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047047543
Device count
150
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903234875BD Home Sharps Collector3234873234872016-08-03
30382903249061BD Veo3249063249062018-02-23
30382903249078BD Veo3249073249072018-02-23
30382903249085BD Veo3249083249082018-02-23
30382903282785BD Ultra-Fine3282783282782016-08-03
30382903282792BD Ultra-Fine3282793282792016-08-03
30382903282808BD Ultra-Fine3282803282802016-08-03
30382903282891BD Ultra-Fine3282893282892016-08-03
30382903282907BD Ultra-Fine3282903282902016-08-03
30382903282914BD Ultra-Fine3282913282912016-08-03
30382903294108BD Micro-Fine3294103294102016-08-03
30382903294122BD Micro-Fine3294123294122016-08-03
30382903294207BD Micro-Fine3294203294202016-08-03
30382903294245BD Micro-Fine3294243294242016-08-03
30382903294610BD Micro-Fine3294613294612016-08-03
30382903294658BD Micro-Fine3294653294652016-08-03
00382903249091BD Veo3249093249092018-02-23
00382903249107BD Veo3249103249102018-02-23
00382903249114BD Veo3249113249112018-02-23
00382903249121BD Veo3249123249122018-02-23

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