FDA.reportPublic FDA data

DOSI-FLOW

Primary DI
18436020769181
Brand
DOSI-FLOW
Company
LEVENTON SAU
Model
L2590263S-SL-NF-US
Device description
Regulator IV Set with Universal Spike (20 drops/mL) with 15 Micron Filter, On/Off Clamp, Flow Regulator, Needle-Free Injection Site, and Rotating Luer Lock Connector
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K952810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952810000DOSI-FLOW, MODELS 20 & 30Leventon, S.A.1995-09-08FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18436020769181PackageGS150In Commercial Distribution
08436020769184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843602076918118436020769181
08436020769184084360207691848436020769184

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
461437429
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08436020768828DOSI-FLOWL2590252MS-MEG2023-08-10
08436020768835DOSI-FLOWL2590253S-FP-MEG2023-08-10
08436020769207DOSI-FLOWL2590253-MEG2023-08-10
08436020760099DOSI-FLOWL2590000502016-11-30
08436020760563DOSI-FLOWL2590000972016-11-30
08436020760914DOSI-FLOWL2590001502016-11-30
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
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840010266Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010372Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010389Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30