FDA UDI
In Commercial Distribution
🇺🇸 United States
JUD care
DI: 06973495370047
·
Model: LWR-01
·
Shenzhen Juding Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JUD care
- Primary DI
- 06973495370047
- Version / Model
- LWR-01
- Company Name
- Shenzhen Juding Medical Co., Ltd.
- Labeler DUNS
- 420584221
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 1
- Public Version Date
- 2021-03-16
- Public Version Status
- New
- Public Device Record Key
- 75022008-d308-4d75-9a87-9f2c555b8035
Device Description
Accessory, Purification Filters,
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FZH | Apparatus, Air Handling, Room | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63709 | Patient isolation tent | A mobile device designed to be erected to provide environmental isolation of a contagious patient to protect hospital personnel and other patients from exposure to non-airborne infections (e.g., diphtheria, meningococcus) whilst the patient is being treated. It includes a collapsible frame with a canopy, designed to create a small room environment for healthcare personnel to enter, and it includes an electric air filtration mechanism; the air in the chamber is filtered before it is returned to the normal external atmosphere. It may include additional features (e.g., electric door mechanism). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973495370047 | GS1 |