FDA Registration
Active
🇺🇸 United States
MAYER LABORATORIES
Reg #: 2938651
·
FEI: 2938651
·
Expires 2026
Products
13
Proprietary Names
27
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- MAYER LABORATORIES
- Registration Number
- 2938651
- FEI Number
- 2938651
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1400 Shattuck Ave., Suite 9
- City
- Berkeley
- State
- CA
- ZIP
- 94709
- Country
- US
Regulatory Submissions
- 510(k) Number
- K946374
- PMA Number
- P910064
Owner / Operator
- Firm Name
- MAYER LABORATORIES
- Operator Number
- 2938651
- Address
- 1400 Shattuck Ave, Suite 9
- City
- Berkeley
- State
- CA
- Postal Code
- 94709
- Country
- US
- Correspondent
- DAVID P MAYER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2012-08-14 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2020-07-29 |
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2020-07-29 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2008-03-24 |
| Condom, Synthetic | MOL | Class 2 | Obstetrics/Gynecology | No | 2008-03-24 |
| Pad, Menstrual, Intralabial | NUR | Class 1 | Obstetrics/Gynecology | No | 2021-06-10 |
| Single-Use Internal Condom | MBU | Class 2 | Obstetrics/Gynecology | No | 2008-03-24 |
| Device, Incontinence, Urosheath Type, Sterile | EXJ | Class 1 | Gastroenterology, Urology | No | 2001-11-29 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-03-05 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2008-03-24 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2023-03-08 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2008-03-24 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2008-03-24 |
Proprietary Names
Kimono Thin
Kimono MicroThin Large
Kimono MicroThin Variety Pack
Kimono MAXX
Digitex
EZON
Kimono MicroThin XL
FC Female Condom
N/A
Aqua Lube Natural Patient Lubricant
Aqua Lube Patient Lubricant
Kimono
Callvin
Kimono Colors
AQUA LUBE
Kimono MicroThin Ribbed + Sensi-dots
Kimono Special
Kimono Textured
Kimono MicroThin
KIMONO MICROTHIN WITH AQUA LUBE
Blossom Organics® Warm Sensation Lubricant
Blossom Organics® Natural Moisturizing Lubricant
Aqua Lube® Natural Personal Lubricant - Regular
Aqua Lube® Natural Gel
Kimono Swirl Natural Lubricant
Nauox Personal Lubricant with flavors
Kimono MAXX Flare
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility