FDA UDI
In Commercial Distribution
🇺🇸 United States
Copioumed
DI: 04719882250644
·
Model: LCN0B101-1
·
COPIOUMED INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Copioumed
- Primary DI
- 04719882250644
- Version / Model
- LCN0B101-1
- Company Name
- COPIOUMED INTERNATIONAL INC.
- Labeler DUNS
- 658318113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-09-02
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- 116843dc-319c-47c5-81a8-522169355708
Device Description
Copioumed’s Lab Coat designed to protect health professionals and patients for cross contamination. Single use. Latex free. Coat made of non-woven material with knitted collar and cuffs.
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FME | Gown, Examination | General Hospital | 880.6265 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32170 | Professional examination gown, single-use | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14719882250641 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 04719882250644 | GS1 | ||||
| Unit of Use | 04719882250637 | GS1 |
Customer Contacts
- Phone
- +886227721815
- [email protected]