FDA.reportPublic FDA data

Steripath

Primary DI
00858366007139
Brand
Steripath
Company
Magnolia Medical Technologies, Inc.
Model
27BD-21UT-EN
Catalog number
27BD-21UT-EN
Device description
Steripath Blood Collection System, Sterile Pack, 21G UltraTouch, Long Neck TA
Published
2024-01-08
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
K192247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192247000Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc.2020-02-28JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858366007511PackageGS110In Commercial Distribution
10858366007136PackageGS110In Commercial Distribution
00858366007139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858366007511008583660075118583660075110858366007511
1085836600713610858366007136
00858366007139008583660071398583660071390858366007139

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
Kit
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10197344216123MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-24
30382903679929BD Vacutainer® SST™ Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2026-07-20
10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216130MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216147MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216154MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216161MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216178MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10813153028329CodanCodan US CorporationFPA2026-07-17
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720466C-QuestLifeOutcomes LLCJKA2026-07-14