PURCEL LABS LLC

FDA Device Registration & Listing · Los Angeles, CA, US · Registration 3021286079

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021286079
FEI Number
3021286079
Entity Name
PURCEL LABS LLC
City/State/Country
Los Angeles, CA, US
Establishment Address
10537 Santa Monica Blvd. Unit 300, Los Angeles, CA 90025, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PurCel Labs LLC (Owner Number: 10083940)
Owner / Operator Contact Address
10537 Santa Monica Blvd. Unit 300, Los Angeles, CA 90025, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K123869
PMA Number
N/A

All Registered Proprietary Names

Isolation Gown Easy Result Blood Glucose Meter System Disposable Insulin Pen Needle Safety Lancets Push-Button Nitrile Exam chemotherapy gloves 4mil black nitrile exam gloves

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2023-12-26
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2024-12-03
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-12-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-06-23
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-05-13
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-07-19
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2024-12-03
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2025-04-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-03-06
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-03-06
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-03-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-03-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-09-11

Official Correspondent

Doron Wipranik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PurCel Labs LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021286079. Last updated year: 2026. Please use registration number 3021286079 when referencing this establishment in official correspondence.
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