FDA UDI
In Commercial Distribution
🇺🇸 United States
Medegen Medical Products, LLC
DI: 00700812003472
·
Model: 17-0907-1
·
MEDEGEN MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Medegen Medical Products, LLC
- Primary DI
- 00700812003472
- Version / Model
- 17-0907-1
- Company Name
- MEDEGEN MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 055527753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2020-12-20
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- 965e2c3a-4371-4056-bb16-65076eeb2ed8
Device Description
Washcloth: Wh 13.5X10 500/cs
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KME | BEDDING, DISPOSABLE, MEDICAL | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37978 | Assistive bathing washcloth | A device designed to be used by a person with a disability to assist them in attending to their personal body washing needs. It is a washcloth made of textile material that will have a purpose-made handle or grip to facilitate its use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00700812003472 | GS1 | ||||
| Unit of Use | 10700812003479 | GS1 |