FDA.reportPublic FDA data

BioFlo

Primary DI
H965464701
Brand
BioFlo
Company
NAVILYST MEDICAL, INC.
Model
46470
Device description
BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150407000BioFlo Midline CatheterNavilyst Medical, Inc.2015-05-15FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965464701PackageHIBCC5In Commercial Distribution
H965464700PrimaryHIBCC0
15051684027038SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402703815051684027038

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length20Centimeter
Needle Gauge21Gauge
Outer Diameter1.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
Device count
1
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
H74904490200NAMIC04490202016-09-20
H965457480AngioDynamics457482016-09-20
H965457490AngioDynamics457492016-09-20
H965457500AngioDynamics457502016-09-20
H965457510AngioDynamics457512016-09-20
H965457520AngioDynamics457522016-09-20
H965457530AngioDynamics457532016-09-20
H965457540AngioDynamics457542016-09-20
H965457550AngioDynamics457552016-09-20
H965457560AngioDynamics457562016-09-20
H965457570AngioDynamics457572016-09-20
H965457580AngioDynamics457582016-09-20
H965457590AngioDynamics457592016-09-20
H965457600AngioDynamics457602016-09-20
H965457610AngioDynamics457612016-09-20
H965457620AngioDynamics457622016-09-20
H965457630AngioDynamics457632016-09-20
H965457640AngioDynamics457642016-09-20
H965457650AngioDynamics457652016-09-20
H965457660AngioDynamics457662016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
10801902102901ARROWTELEFLEX INCORPORATEDFOZ2019-12-10
10801902130331ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130355ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130379ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902133004ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133028ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133042ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133066ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133080ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133233ARROWTELEFLEX INCORPORATEDFOZ2017-03-08
10801902133127ARROWTELEFLEX INCORPORATEDFOZ2017-03-07
10801902132816ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902132823ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133097ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133103ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902131529ARROWTELEFLEX INCORPORATEDFOZ2017-02-17
10801902131512ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
10801902131567ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
00801741074769Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
00801741074783Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130935ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902129359ARROWTELEFLEX INCORPORATEDFOZ2016-11-11