FDA.reportPublic FDA data

RegenKit-ATS-T-U

Primary DI
00850033131178
Brand
RegenKit-ATS-T-U
Company
Regenlab USA LLC
Model
RK-ATS-T-U
Published
2025-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PMQPeripheral Blood Processing Device For Wound Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMQPeripheral Blood Processing Device For Wound ManagementHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033131178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033131178008500331311788500331311780850033131178

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, noninvasiveA collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Regulatory Flags#

DUNS number
087434117
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033131185RegenKit-ATS-3-URK-ATS-3-U2025-10-31
00850033131215RegenKit®-BCT-T-URK-BCT-T-U2026-03-25
00850033131208RegenKit®-THT-T-URK-THT-T-U2026-03-23
00850033131055RegenLab USARK-THT-3-U 2023-04-28
08500331310042RegenKit®-BCT-TRK-BCT-T2021-08-27
00850033131192Cellular MembraneCM-HA-1CM-HA-12025-12-04
00850033131116Enhanced HASE-EN-HA-12025-08-29
00850033131123Wound Care Accessory SetWCA-SET12025-08-08
00850033131109RegenLab USARK-THT-BMC-3-102024-04-18
00850033131093RegenKit Wound-GelRK-WG-1SE-RK-WG-12024-03-12
00850033131031RegenLab USARK-BCT-3-U 2023-04-28
00850033131048RegenLab USARK-BCT-3-20-U2023-04-28
00850033131062RegenLab USARK-THT-3-20-U2023-04-28
00850033131079RegenLab USARK-WG-22023-04-28
00850033131086RegenLab USAR-ET2023-04-28
00850033131024Accessory SetBCA-SET3-U2021-11-24
00850033131017Accessory SetBCA-SET3-202021-11-19
08500331310028Accessory SetBCA-SET3-U2021-10-22
08500331310035Accessory SetBCA-SET3-202021-10-22
08500331310011A-CP-Kit-3A-CP-32021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033131192Cellular MembraneRegenlab USA LLCPMQ2025-12-04
00850033131185RegenKit-ATS-3-URegenlab USA LLCPMQ2025-10-31
00850047730305Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.PMQ2025-09-17
00852714003279CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003286CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003293CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003309CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003323CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003330CentrioNuo Therapeutics, Inc.PMQ2025-09-01
00852714003347CentrioNuo Therapeutics, Inc.PMQ2025-09-01
10860000244319ActiGraftREDDRESS LTDPMQ2025-03-23
00860000244312ActiGraftREDDRESS LTDPMQ2025-03-23
008527140032484TRNuo Therapeutics, Inc.PMQ2024-03-21
00850033131093RegenKit Wound-GelRegenlab USA LLCPMQ2024-03-12
00850047730008Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730015Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730022Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730039Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730046Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730053Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730060Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
00850047730077Foundation DRS SoloBionova Medical Inc.PMQ2023-07-05
07640138981616RegenPlasma/RegenKit-Woud Gel-2REGEN LAB SAPMQ2023-01-19
057141883018083CP™ CounterbalanceReapplix ApSPMQ2019-05-23
057141883080053CP™ Centrifuge KitReapplix ApSPMQ2019-05-23
057141885010003C Patch® Needle HolderReapplix ApSPMQ2019-05-23