FDA UDI
In Commercial Distribution
🇺🇸 United States
Copioumed
DI: 14719882250870
·
Model: SHN0W201-1
·
COPIOUMED INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
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Basic Information
- Brand Name
- Copioumed
- Primary DI
- 14719882250870
- Version / Model
- SHN0W201-1
- Company Name
- COPIOUMED INTERNATIONAL INC.
- Labeler DUNS
- 658318113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-09-06
- Public Version
- 1
- Public Version Date
- 2022-09-14
- Public Version Status
- New
- Public Device Record Key
- b3f57e8c-e839-4d19-adb8-f24f9287a319
Device Description
Copioumed’s Protective Shoe Cover is used by medical personnel in medical institutions to prevent contact with potentially infectious patient blood, body fluids, secretions, etc., and play a barrier and protection role.
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
- No
- 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 |
|---|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15056 | Shoe cover | A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04719882250873 | GS1 | ||||
| Primary | 14719882250870 | GS1 |
Customer Contacts
- Phone
- +886227721815
- [email protected]