FDA UDI
In Commercial Distribution
🇺🇸 United States
Derma Therapy
DI: 00857268006905
·
Model: DT-MCM-3680Y-EA
·
JOERNS HEALTHCARE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Derma Therapy
- Primary DI
- 00857268006905
- Version / Model
- DT-MCM-3680Y-EA
- Company Name
- JOERNS HEALTHCARE, LLC
- Labeler DUNS
- 790937150
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-27
- Public Version
- 1
- Public Version Date
- 2020-06-04
- Public Version Status
- New
- Public Device Record Key
- 140b5922-8241-4e85-9ac8-6626a12e7ba5
Device Description
DermaTherapy MED Linen;FIT 36X80 EA
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
- 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 |
|---|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | 880.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62028 | Antimicrobial bed linen set | A collection of non-sterile devices including, but not limited to, a bed sheet(s), pillowcase, duvet cover and mattress cover, intended to be used to provide cover/protection to a bed and associated items. The components are treated/impregnated with an antimicrobial substance to control bacterial and fungal growth on the fabric and reduce the levels of house dust mites (HDM) and their allergen-containing faecal droppings. The device is typically made of a thin-textile or reinforced-paper material, to be used in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20857268006909 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00857268006905 | GS1 |