Enhanced HA

GUDID 00850033131116

Regenlab USA LLC

Blood collection set, noninvasive
Primary Device ID00850033131116
NIH Device Record Key374698cd-4b34-4078-bb8f-41805154bcff
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnhanced HA
Version Model NumberSE-EN-HA-1
Company DUNS087434117
Company NameRegenlab USA LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033131116 [Primary]

FDA Product Code

KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-08
Device Publish Date2025-08-29

Devices Manufactured by Regenlab USA LLC

00850033131116 - Enhanced HA2025-09-08
00850033131116 - Enhanced HA2025-09-08
00850033131123 - Wound Care Accessory Set2025-08-18
00850033131109 - RegenLab USA2024-04-26 RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10
00850033131093 - RegenKit Wound-Gel2024-03-20 .
00850033131031 - RegenLab USA2023-05-08
00850033131048 - RegenLab USA2023-05-08
00850033131055 - RegenLab USA2023-05-08
00850033131062 - RegenLab USA2023-05-08
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