FDA UDI
In Commercial Distribution
🇺🇸 United States
BRANDMAX
DI: 04961333244355
·
Model: U-5LH
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BRANDMAX
- Primary DI
- 04961333244355
- Version / Model
- U-5LH
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-15
- Public Version
- 2
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- c295c360-d7be-4518-8744-98615da1b426
Device Description
BRANDMAX TRI CLEAN ULTRASONIC CLEANER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | 880.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48122 | Non-submersible device disinfection chamber | A vessel designed to protect the part of a device that cannot be exposed to liquid cleaning agents or disinfectant [e.g., the electrical connector of a transoesophageal echocardiography (TOE) probe] in a water-tight vault that may be air-pressurized, so the patient-contact part of the device can be nonthermally, chemically decontaminated and/or high-level disinfected (e.g., in an automated endoscope washer/disinfector). It is typically made of metals and polymers [e.g., stainless steel, silicone, and polycarbonate (PC)] and consists of a housing with a clamp, seal, cap, and/or valves. It is typically used in instrument and endoscopy cleaning rooms. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333244355 | GS1 |