FDA UDI
In Commercial Distribution
🇺🇸 United States
Relish
DI: 06970075431006
·
Model: RL1501
·
Shenzhen Relish Technology Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Relish
- Primary DI
- 06970075431006
- Version / Model
- RL1501
- Catalog Number
- 3004
- Company Name
- Shenzhen Relish Technology Co.,Ltd
- Labeler DUNS
- 421345206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 30d50aac-415a-452c-b3c7-3f89108c035b
Device Description
Irrigator
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FQH | LAVAGE, JET | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17189 | Gastric lavage system | A device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris (e.g., toxic substances) from the stomach. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated liquid (e.g., saline); an extractor (frequently using vacuum) and controls for liquid temperature/pressure and rate of liquid infusion/withdrawal; and bags for the irrigation solution and waste. Most systems can deliver charcoal to the stomach for absorption of toxic substances; they are mainly used in emergency departments and for cleaning/evacuation of the stomach before some endoscopic and/or surgical procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970075431006 | GS1 |
Customer Contacts
- Phone
- +86075589339275
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 200 | Milliliter |