FDA.reportPublic FDA data

SteriPath Gen2, 21G, BD

Primary DI
00858366007030
Brand
SteriPath Gen2, 21G, BD
Company
Magnolia Medical Technologies, Inc.
Model
27BD-21-EN
Catalog number
27BD-21-EN
Device description
Steripath Blood Collection System, Sterile Pack, 21G, Long Neck TA
Published
2020-11-06
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
10858366007037PackageGS110In Commercial Distribution
00858366007030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085836600703710858366007037
00858366007030008583660070308583660070300858366007030

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
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B098AMS188510Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188520Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
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01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
06971564461696ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
06971564461702ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
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00859776006033K-QUE-SAR-SHIPPERQuest DiagnosticsJKA2026-09-15
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
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10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
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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
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00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30