FDA Registration
Active
🇺🇸 United States
PURCEL LABS LLC
Reg #: 3021286079
·
FEI: 3021286079
·
Expires 2026
Products
15
Proprietary Names
12
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- PURCEL LABS LLC
- Registration Number
- 3021286079
- FEI Number
- 3021286079
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10537 Santa Monica Blvd. Unit 300
- City
- Los Angeles
- State
- CA
- ZIP
- 90025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191657
Owner / Operator
- Firm Name
- PurCel Labs LLC
- Operator Number
- 10083940
- Address
- 10537 Santa Monica Blvd. Unit 300
- City
- Los Angeles
- State
- CA
- Postal Code
- 90025
- Country
- US
- Correspondent
- Doron Wipranik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2023-12-26 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-12-03 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-12-03 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2023-06-23 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-05-13 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-07-19 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2024-12-03 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2025-04-09 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-03-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-03-06 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-03-06 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-03-06 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-08-13 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2023-10-23 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2023-12-26 |
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
Surgical Masks (ASTM Level 1)
Vinyl Exam Gloves
Blue Vinyl Exam Gloves
Examination Gown
Safety Insulin Pen Needles
Blue Nitrile Exam Gloves (Chemo Rated)
Establishment Types
Repack or Relabel Medical Device