FDA.reportPublic FDA data

Steripath Flow

Primary DI
00858366007801
Brand
Steripath Flow
Company
Magnolia Medical Technologies, Inc.
Model
50BD-21UT-EN
Catalog number
50BD-21UT-EN
Device description
Steripath Flow, 21G UltraTouch, Long Neck TA
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
00858366007818PackageGS14In Commercial Distribution
10858366007808PackageGS125In Commercial Distribution
00858366007801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858366007818008583660078188583660078180858366007818
1085836600780810858366007808
00858366007801008583660078018583660078010858366007801

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
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
00858366007900Steripath Flow5010-23UT-EN5010-23UT-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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00850048720237C-QuestLifeOutcomes LLCJKA2026-07-09
50192253051153CARDINAL HEALTHCardinal Health 200, LLCJKA2026-06-25
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29