FDA.reportPublic FDA data

Enhanced HA

Primary DI
00850033131116
Brand
Enhanced HA
Company
Regenlab USA LLC
Model
SE-EN-HA-1
Published
2025-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033131116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033131116008500331311168500331311160850033131116

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033131178RegenKit-ATS-T-URK-ATS-T-U2025-10-31
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
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
10885380191077CARDINAL HEALTHCardinal Health 200, LLCKST2026-06-08
00199874715100Life PRP LLCLife PRP, LLCKST2026-05-30
00850087212007Life PRP LLCLife PRP, LLCKST2026-05-30
00850024924109Labcorp Comfort DrawMEDTOX DIAGNOSTICS, INC.KST2026-05-22
H671ABCTD0ABC TinyDrawUTAH MEDICAL PRODUCTS, INC.KST2025-09-18
00810185250509TherapakTherapak LLCKST2025-08-11
00810185250516TherapakTherapak LLCKST2025-08-11
04719875918100Transcend Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-08-07
20193489189664MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
30193489189661MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
10810100050457KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050587KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172676KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050078KBMEDKB Medical (group), Inc.KST2025-05-21
00850016172013KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050075KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050450KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050580KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172010KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050454KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050584KBMEDKB Medical (group), Inc.KST2025-05-21
20850016172673KBMEDKB Medical (group), Inc.KST2025-05-21
04719875918070Aeon Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
04719875918094Virtue Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
10888277415461MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
20888277415468MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
06974481839128Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974481839125Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
06974481839142Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974594960051N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01