FDA UDI
In Commercial Distribution
🇺🇸 United States
sam(R) Advanced Gel Capture Patch
DI: 00857599005257
·
Model: UB-14
·
ZETROZ SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
15
Basic Information
- Brand Name
- sam(R) Advanced Gel Capture Patch
- Primary DI
- 00857599005257
- Version / Model
- UB-14
- Catalog Number
- UB-14-15W
- Company Name
- ZETROZ SYSTEMS, LLC
- Labeler DUNS
- 080128497
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2024-10-10
- Public Version
- 2
- Public Version Date
- 2026-03-17
- Public Version Status
- Update
- Public Device Record Key
- 5a1ce162-2322-4575-b83d-acc336a1c739
Device Description
coupling patch for use with sam wearable ultrasound device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15321 | Skin topical coupling gel | A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light, blood gas) that pass through the skin during an examination or treatment. Also known as contact gel, it is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00857599005165 | GS1 | case | 4 | In Commercial Distribution | |
| Primary | 00857599005257 | GS1 | ||||
| Unit of Use | 00857599005103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191568 | 000 |