FDA UDI
In Commercial Distribution
🇺🇸 United States
COMFORT TOUCH
DI: 00850024759091
·
Model: UNDER PADS
·
Slv Pharmaceuticals LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMFORT TOUCH
- Primary DI
- 00850024759091
- Version / Model
- UNDER PADS
- Company Name
- Slv Pharmaceuticals LLC
- Labeler DUNS
- 081225162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 1
- Public Version Date
- 2020-11-26
- Public Version Status
- New
- Public Device Record Key
- 7af1f4e8-e052-4b46-9f50-9f77286bd92e
Device Description
Comfort Touch Adult Underpads, 30" x 36"
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | General Hospital | 880.5630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61848 | Absorbent underpad, antimicrobial | A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It includes a pharmaceutical antibacterial agent [e.g., silver (Ag)] and typically helps to eliminate unwanted odours. It is intended to be used in the healthcare facility and in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850024759091 | GS1 |