FDA.reportPublic FDA data

Pro-Flo™

Primary DI
00613994941770
Brand
Pro-Flo™
Company
MEDTRONIC, INC.
Model
010315
Device description
CATHETER 010315 PF 10PK 7F 100 IMA
Published
2016-06-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHMAPPARATUS, SUTURING, STOMACH AND INTESTINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHMApparatus, Suturing, Stomach And IntestinalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994941774PackageGS110Not in Commercial Distribution
00613994941770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399494177420613994941774
00613994941770006139949417706139949417700613994941770

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Length100Centimeter
Lumen/Inner Diameter1.55Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store catheters in a cool, dry area.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733103322Para-Pak CLEANMERIDIAN BIOSCIENCE, INC.FHM2021-06-18
10884521048980TA PremiumCovidien LPFHM2018-08-19
10884521031630GIA PremiumCovidien LPFHM2018-08-10
10884521045965Premium Multifire TACovidien LPFHM2018-08-10
10884523007091GIA PremiumCovidien LPFHM2018-08-10
20884521045962Premium Multifire TACovidien LPFHM2018-08-10
20884523007098GIA PremiumCovidien LPFHM2018-08-10
10884521063402GIA PremiumCovidien LPFHM2018-08-10
10884521048997TA PremiumCovidien LPFHM2018-08-10
10884521049000TA PremiumCovidien LPFHM2018-08-10
10884521049024TA 90 BNCovidien LPFHM2018-08-10
20884521031637GIA PremiumCovidien LPFHM2018-08-10
00815277020633CuraplexBOUND TREE MEDICAL, LLCFHM2016-12-14
00815277027779CuraplexBOUND TREE MEDICAL, LLCFHM2016-12-14
00815277027786CuraplexBOUND TREE MEDICAL, LLCFHM2016-12-14
20613994941774Pro-Flo™MEDTRONIC, INC.FHM2016-06-13