FDA UDI
In Commercial Distribution
🇺🇸 United States
Action®
DI: 00089904003164
·
Model: Commode Pad
·
ACTION PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Action®
- Primary DI
- 00089904003164
- Version / Model
- Commode Pad
- Catalog Number
- COM1818
- Company Name
- ACTION PRODUCTS, INC.
- Labeler DUNS
- 067543058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-09
- Public Version
- 1
- Public Version Date
- 2021-02-17
- Public Version Status
- New
- Public Device Record Key
- d9babe8d-9855-4cfb-91bf-f7d5242380dd
Device Description
Commode Pad
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KIC | Cushion, Flotation | Physical Medicine | 890.3175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35631 | Toilet cushion | A soft pillow or pad designed to provide support, comfort, and assistance to the user while sitting on a toilet or commode seat. The device is designed to evenly distribute body weight, absorb shock, and adjust height for the user who has difficulty bending to or rising from a low position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089904003164 | GS1 |
Customer Contacts
- Phone
- 301.797.1414
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in clean, dry environment
- Type
- Special Storage Condition, Specify
- Special Conditions
- Minimal UV exposure