FDA UDI
In Commercial Distribution
🇺🇸 United States
Resilient Medical Solutions
DI: 00850037100415
·
Model: RMIN21
·
Resilient Medical Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Resilient Medical Solutions
- Primary DI
- 00850037100415
- Version / Model
- RMIN21
- Company Name
- Resilient Medical Solutions, LLC
- Labeler DUNS
- 076404432
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-13
- Public Version
- 2
- Public Version Date
- 2023-04-07
- Public Version Status
- Update
- Public Device Record Key
- 3d6897ce-8f92-4a4c-8845-8ea571cbfb44
Device Description
Knit Pants, Washable - 2XL/3XL, Waist 39-59 in (100-150 cm), 4 bags/case
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
- No
- 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 |
|---|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | 876.5920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35120 | Incontinence pants, reusable | An underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a reusable man?s brief or woman?s panty with external softness and shape resembling regular underwear, and a disposable pant liner and/or a tube that deliver the urine to a bag placed on or around one leg. The device is typically used for patients with heavy urinary incontinence in healthcare facilities or at home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850037100415 | GS1 | ||||
| Package | 10850037100412 | GS1 | Case | 4 | In Commercial Distribution |