FDA UDI
In Commercial Distribution
🇺🇸 United States
DR -HOS
DI: 06970742221671
·
Model: DHGEL
·
Guangzhou Xinbo Electronic Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DR -HOS
- Primary DI
- 06970742221671
- Version / Model
- DHGEL
- Company Name
- Guangzhou Xinbo Electronic Co., Ltd.
- Labeler DUNS
- 530683813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-16
- Public Version
- 1
- Public Version Date
- 2021-08-24
- Public Version Status
- New
- Public Device Record Key
- 66a5e812-8a24-4ae3-b859-249aefada989
Device Description
Conductive Electrode Gel: a conductive medium for use on fabric or metal electrodes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GYB | Media, Electroconductive | Neurology | 882.1275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32544 | Mediastinal drainage catheter, non-antimicrobial | A tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970742221671 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200402 | 000 |