FDA UDI
In Commercial Distribution
🇺🇸 United States
Jenshhch
DI: 16974058870070
·
Model: 7007
·
Saibainian Medical Technology (Wuhan) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jenshhch
- Primary DI
- 16974058870070
- Version / Model
- 7007
- Company Name
- Saibainian Medical Technology (Wuhan) Co., Ltd.
- Labeler DUNS
- 636638075
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-19
- Public Version
- 1
- Public Version Date
- 2024-03-27
- Public Version Status
- New
- Public Device Record Key
- 04754d1b-2df1-42bb-8e9c-346821cc2506
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31076 | Multiple-piece intestinal ostomy bag, open-ended | A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 16974058870070 | GS1 |