FDA UDI
In Commercial Distribution
🇺🇸 United States
Chongjen
DI: 06974681690482
·
Model: Lab Coat,M
·
SHANGHAI CHONGJEN INDUSTRY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chongjen
- Primary DI
- 06974681690482
- Version / Model
- Lab Coat,M
- Company Name
- SHANGHAI CHONGJEN INDUSTRY CO., LTD.
- Labeler DUNS
- 560012294
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-18
- Public Version
- 1
- Public Version Date
- 2023-01-26
- Public Version Status
- New
- Public Device Record Key
- 1d786b36-e9c0-4ec2-b5ee-59eb2279c8f2
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
- 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 |
|---|---|---|---|---|
| OEA | Non-Surgical Isolation Gown | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41113 | Assistive coat | An over garment (e.g., an overcoat or jacket) specially designed/adapted to be worn by a person with a disability for outdoor use. It may be worn by a male or a female and is typically constructed with features to facilitate easy donning, fastening, and removal (e.g., wide sleeves, large pockets, Velcro or zip fasteners). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974681690482 | GS1 |