FDA UDI
Not in Commercial Distribution
🇺🇸 United States
UNDERPAD TRUVAL
DI: 00634916043129
·
Model: 59785100
·
STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- UNDERPAD TRUVAL
- Primary DI
- 00634916043129
- Version / Model
- 59785100
- Catalog Number
- 59785100
- Company Name
- STANDARD TEXTILE CO., INC.
- Labeler DUNS
- 006999858
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2018-01-29
- Public Version
- 5
- Public Version Date
- 2024-01-16
- Public Version Status
- Update
- Public Device Record Key
- 7c85a4fc-2bf1-4b4e-b6d7-06d5ce4124e3
- Distribution End Date
- 2023-12-28
Device Description
UNDERPAD TRUVAL 1PLY 36X41 GREEN POLYESTER STAY DRY MESH FACE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 66117 | Absorbent underpad, non-antimicrobial, reusable | A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00634916043129 | GS1 | ||||
| Unit of Use | 10634916043126 | GS1 |
Customer Contacts
- Phone
- 1-800-999-0400
- [email protected]