DOSI-FLOW

Primary DI
08436020760914
Brand
DOSI-FLOW
Company
LEVENTON SAU
Model
L259000150
Device description
I.V. Extension Set with Flow Regulator and Needle Free Injection Site
Published
2016-11-30
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
LDRController, Infusion, Intravascular, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDRController, Infusion, Intravascular, ElectronicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851058000DOSI FLOWLeventon, S.A.1985-04-29LDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18436020760911PackageGS150In Commercial Distribution
08436020760914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843602076091118436020760911
08436020760914084360207609148436020760914

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
461437429
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436020761836TRI-BALLL259120002017-06-12
08436020761843SPIRO-BALLL259130002017-06-12
18436020761833TRI-BALLL259120002017-06-12
18436020761840SPIRO-BALLL259130002017-06-12
08436020769153DOSI-FLOWL2590260-US2023-09-08
08436020769160DOSI-FLOWL2590260-NF-US2023-09-08
08436020769177DOSI-FLOWL2590263S-SL-US2023-09-08
08436020769184DOSI-FLOWL2590263S-SL-NF-US2023-09-08
18436020769150DOSI-FLOWL2590260-US2023-09-08
18436020769167DOSI-FLOWL2590260-NF-US2023-09-08
18436020769174DOSI-FLOWL2590263S-SL-US2023-09-08
18436020769181DOSI-FLOWL2590263S-SL-NF-US2023-09-08
08436020768828DOSI-FLOWL2590252MS-MEG2023-08-10
08436020768835DOSI-FLOWL2590253S-FP-MEG2023-08-10
08436020769207DOSI-FLOWL2590253-MEG2023-08-10
08436020760099DOSI-FLOWL2590000502016-11-30
08436020760563DOSI-FLOWL2590000972016-11-30
08436020761362DOSI-FLOWL2590253-VICTUS2016-11-30
08436020761706DOSI-FLOWL2590263-VICTUS2016-11-30
08436020763465DOSI-FLOWL2590003302016-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436020769153DOSI-FLOWLEVENTON SAULDR2023-09-08
08436020769160DOSI-FLOWLEVENTON SAULDR2023-09-08
18436020769150DOSI-FLOWLEVENTON SAULDR2023-09-08
18436020769167DOSI-FLOWLEVENTON SAULDR2023-09-08
08436020760099DOSI-FLOWLEVENTON SAULDR2016-11-30
18436020760096DOSI-FLOWLEVENTON SAULDR2016-11-30
18436020760911DOSI-FLOWLEVENTON SAULDR2016-11-30
00856038001096IradimedIRADIMED CORP.LDR2016-08-25