FDA.reportPublic FDA data

Steripath Flow

Primary DI
00858366007900
Brand
Steripath Flow
Company
Magnolia Medical Technologies, Inc.
Model
5010-23UT-EN
Catalog number
5010-23UT-EN
Device description
Steripath Flow, 23G UltraTouch, 10mL Syringe
Published
2025-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251812000Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies2025-09-25JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858366007917PackageGS14In Commercial Distribution
10858366007907PackageGS125In Commercial Distribution
00858366007900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858366007917008583660079178583660079170858366007917
1085836600790710858366007907
00858366007900008583660079008583660079000858366007900

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.

Regulatory Flags#

DUNS number
078603710
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858366007726Steripath Flow5000-EN5000-EN2025-11-25
00858366007740Steripath Flow5000-21UT-EN5000-21UT-EN2025-11-25
00858366007764Steripath Flow5000-23UT-EN5000-23UT-EN2025-11-25
00858366007788Steripath Flow50BD-EN50BD-EN2025-11-25
00858366007801Steripath Flow50BD-21UT-EN50BD-21UT-EN2025-11-25
00858366007825Steripath Flow50BD-23UT-EN50BD-23UT-EN2025-11-25
00858366007849Steripath Flow5005-EN5005-EN2025-11-25
00858366007863Steripath Flow5005-23UT-EN5005-23UT-EN2025-11-25
00858366007887Steripath Flow5010-EN5010-EN2025-11-25
10858366007723Steripath Flow5000-EN5000-EN2025-11-25
10858366007747Steripath Flow5000-21UT-EN5000-21UT-EN2025-11-25
10858366007761Steripath Flow5000-23UT-EN5000-23UT-EN2025-11-25
10858366007785Steripath Flow50BD-EN50BD-EN2025-11-25
10858366007808Steripath Flow50BD-21UT-EN50BD-21UT-EN2025-11-25
10858366007822Steripath Flow50BD-23UT-EN50BD-23UT-EN2025-11-25
10858366007846Steripath Flow5005-EN5005-EN2025-11-25
10858366007860Steripath Flow5005-23UT-EN5005-23UT-EN2025-11-25
10858366007884Steripath Flow5010-EN5010-EN2025-11-25
10858366007907Steripath Flow5010-23UT-EN5010-23UT-EN2025-11-25
00858366007153Steripath2710-21UT-EN2710-21UT-EN2024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYJKA2024-06-06
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached HolderBECTON, DICKINSON AND COMPANYJKA2024-03-25
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGJKA2024-02-20
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
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGJKA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGJKA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGJKA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06