FDA.reportPublic FDA data

Steripath Flow

Primary DI
10858366007907
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
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078603710
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
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
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
00858366007153Steripath2710-21UT-EN2710-21UT-EN2024-01-08

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Primary DI, Brand, Company table
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05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
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
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
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00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06