Cellular Membrane CM-HA-1

GUDID 00850033131192

Cellular Membrane 1 pk 10ml

Regenlab USA LLC

Blood collection set, noninvasive
Primary Device ID00850033131192
NIH Device Record Key897c05ff-747d-4508-b064-2e817cf185c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCellular Membrane
Version Model NumberCM-HA-1
Catalog NumberCM-HA-1
Company DUNS087434117
Company NameRegenlab USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS100850033131192 [Primary]

FDA Product Code

PMQPeripheral Blood Processing Device For Wound Management

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-12
Device Publish Date2025-12-04

Devices Manufactured by Regenlab USA LLC

00850033131192 - Cellular Membrane2025-12-12Cellular Membrane 1 pk 10ml
00850033131192 - Cellular Membrane2025-12-12 Cellular Membrane 1 pk 10ml
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
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