FDA.reportPublic FDA data

Medtronic MiniMed Pro-Set Infusion Set, PCAP Connection 42in

Primary DI
50382903286152
Brand
Medtronic MiniMed Pro-Set Infusion Set, PCAP Connection 42in
Company
Becton, Dickinson and Company Inc
Model
328615
Catalog number
328615
Device description
MINIMED 42IN PCAP MMT-281
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
50382903286152PackageGS115In Commercial Distribution
00382903286157PrimaryGS10
00382903673230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290328615250382903286152
00382903286157003829032861573829032861570382903286157
00382903673230003829036732303829036732300382903673230

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
Length42Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047047543
Device count
150
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
false
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
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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